Accurate Cutting About and Into Tissue Volumes with Electrosurgically Deployed Electrodes

ABSTRACT

Method, system and apparatus for carrying out accurate electrosurgical cutting. A thin resilient electrode is utilized at the forward end region of an instrument that is deployable from a longitudinally disposed slot positioned rearwardly of the tip of the instrument. Lateral sides of the slot extend between a forward location adjacent the tip and a rearward location. The electrode is deployed by urging it forwardly in compression to form an arch profile supported by the abutting slot sides adjacent the forward and rearward locations. Electrosurgically excitable with a cutting output, the electrode may carry out a cutting action both during its deployment and retraction into the noted slot. This permits a pivoting maneuver effective for circumscribing a volume of targeted tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.11/059,823, filed Feb. 17, 2005, which is a division of U.S. patentapplication Ser. No. 10/238,376, filed Sep. 10, 2002, now U.S. Pat. No.7,335,198, issued Feb. 26, 2008, which is a continuation of U.S. patentapplication Ser. No. 09/418,923, filed Oct. 15, 1999, now U.S. Pat. No.6,514,248, issued Feb. 4, 2003.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not applicable.

BACKGROUND OF THE INVENTION

The excision of diseased or abnormal tissue from the body traditionallyhas been termed an “invasive” one. In carrying out invasive surgery,medical practitioners generally have resorted to the use of sharpenededge tools and, for about six decades, additionally, forms ofelectrosurgery. In the latter regard, a somewhat pioneer electrosurgicaldevice was developed by William T. Bovie. This early device, described,for example, in U.S. Pat. No. 1,813,902 issued on Jul. 14, 1931 entitled“Electrosurgical Apparatus” and its successors have met with acceptanceover the years within the surgical community to the extent that currentversions are referred to as the “Bovie”.

For both traditional excision approaches, injury generally occurs tosurrounding or peripheral and healthy tissue. While certain of suchinjuries are apparent, others have been reported which are more subtle.Conventional removal of malignant tumor, as well as more simple biopsyprocedures have been reported to generate “seeding” or spreading ormetastasizing cancer in the body. In addition to patient discomfort andlonger recovery periods, more invasive surgical procedures are reportedto be accompanied by a period of immunosuppression, a conditionincreasing the risk of disease spread. See the following publications inthis regard:

-   -   “Impaired Production of Interlukin-2 after Surgery,” T.        Akiyoshi, et al., Clin. Exp. Immunology, Vol. 59, pp 45-49,        1985.    -   “The Influence of Surgical Operations on Components of the Human        Immune System,” T. Lennard, et al., British J. of Surgery, Vol.        72, pp 771-776, 1985.

Less invasive alternatives to conventional surgical procedures have beenand continue to be investigated, particularly as the clinical detectionof tumor or tissue abnormalities has become more refined. For example,current imaging systems (mammography, ultrasonographs, MRI) may detectand locate very small tumor or tissue abnormalities sized at the levelof a millimeter. Where such tumor is detected, for example, in thebreast, biopsy procedures employing fine needle aspiration techniquesmay be utilized. Retrospective investigation, however, has determinedthat about 80% of such biopsied tissue is benign. Where malignancy isdetermined, the biopsy procedure risks the above-noted seeding ormetastasization opportunities. Excision of even the smaller aberranttissue zones typically is both traumatic to the patient and relativelycost intensive. The latter cost aspect also is present with conventionalneedle biopsy procedures.

Particularly where small tumors or tissue abnormalities are encountered,investigators have looked to potentially less invasive and thus lesscostly and less traumatic procedures. For example, if a smaller tumorcan be biologically destroyed in situ so as to become ischemic ornecrotic, the resultant small zone of dead tissue eventually will bephysiologically eliminated by resorption.

One approach to carrying out an in situ destruction of such smallertargeted tissue zones has been to thermally affect the volume ofaberrant tissue. Such an approach may involve either cooling or heatingthe target tissue to the point of irreversible cell death or necrosis.For the former, cooling approach, reference is made to followingpublication:

-   -   “Requisites for Successful Cryogenic Surgery of Cancer,” H.        Neel, et al., Arch. Surg., Vol. 102, pp 45-48, 1971.

The latter approach, that of inducing therapeutic hyperthermia generallyis a less invasive one. A rather broad variety of technical modalitieshave evolved to elevate the temperature of tissue. For example,biological tissue volumes may be heated by inductive, radiant, contactor joulean based techniques. While these hyperthermic approaches exhibitpotential advantage over the highly invasive surgical modalities,limitations to their use have been identified. Inductively basedsystems, certain of which are described in U.S. Pat. Nos. 5,251,645 and4,679,561 perform by passing high frequency electromagnetic radiationthrough tissue. This is achieved by passing the radiation between twoexternal electrodes positioned adjacent the patient's skin. A drawbackof such an approach to therapeutic hyperthermia resides in the heatingof a relatively large volume of tissue at elevated temperatures forextended intervals of time. Typically with this practice, tissue isheated to temperatures of 6° C. to 10° C. above normal body temperaturefor periods of twenty minutes or more to achieve necrosis. The systemsgenerally do not allow the volume of tissue to be well defined, i.e.,the treatment is inaccurate, resulting in either insufficient necrosisor excessive necrosis extending into surrounding healthy tissue. As aconsequence, practitioners have looked to combining prolonged heating oftissue with chemotherapy or radiation therapy modalities.

Interstitial thermotherapy has become an important alternative toinvasive surgical methods. In general, six thermotherapy modalities havebeen developed for heating or cooling tissue. They are identified as:(1) radiofrequency heating, (2) microwave heating, (3) laser heating,(4) ultrasound heating and (5) cryogenic cooling. Radiofrequency heatingprocedures are categorized as direct and indirect. The latter, indirect,approach involves the placement of metal wires or pellets (which may beautoregulated) in the target tissue and then externally applying an R.F.field.

The above six modalities involve either of two methods of temperaturealteration in tissue, to with, conduction and diffuse or distributedheating of targeted tissue. Conduction may be of heat from or to adevice or instrument and is characterized as a slow process sincethermal diffusion through tissue is a somewhat slow phenomenon. This canlead not only to longer treatment periods but uncertainty in the sizeand shape of the final lesion, again a problem of treatment accuracy.Such conduction-limited modalities include: indirect radiofrequencyheating, laser heating, and cryogenic cooling. Conduction-limitedtherapeutic heating of tissue using radiant sources is described, forexample, in U.S. Pat. Nos. 5,284,144; 4,872,458; and 4,737,628. Radiantsources, such as lasers, produce localized heating of tissue, but do notpermit the affected volume to be predetermined, a priori. Otherconduction-limited contact heating approaches have been used forinducing therapeutic hyperthermia as are described in U.S. Pat. Nos.4,979,518; 4,860,744; 4,658,836; and 4,520,249.

Diffuse or distributed heating of targeted tissue is distinctlydifferent from the above-described conduction-limited method. Thisapproach has the potential advantage that the target tissue can beheated to a desired cauterization temperature within relatively shorterinterval of time. Cauterization procedures involve bringing targetedtissue to a temperature within a predetermined temperature range for aduration resulting in irreversible cell death. However, whilerepresenting a procedure exhibiting much promise, investigators haveencountered obstacles in its implementation. In this regard, the volumeof tissue cauterized is generally more difficult to control for systemsincorporating microwave or ultrasound procedures, inasmuch as theseprocedures depend upon the radiation of tissue-heating energy into avolume of tissue from an emitting transducer or antennae system. Theprecise size of any resulting lesion depends upon the duration oftreatment as well as the microwave or ultrasound responsiveness of thetargeted tissue. In this regard, investigators have looked to theplacement of one or more temperature sensors within the treatment fieldor have looked to the measurement of electrical impedance to assess theextent of the volume of cauterized tissue to determine an end pointtermination of the therapy. The problem of treatment accuracy again isposed. See generally, U.S. Pat. Nos. 5,122,137; 4,776,334; and4,016,866. A direct measurement of tissue impedance is described, forexample, in U.S. Pat. Nos. 5,069,223 and 4,140,109. These procedures arecomplex and somewhat costly. Of the diffuse or distributed heatingapproaches, electrosurgical techniques hold promise for both precise andpredictable cauterization of targeted tissue volume, as well as arapidity of the treatment process. Devices and technology representingthis category are described, for example, in U.S. Pat. Nos. 5,728,143;5,683,384; 5,672,173; 5,672,174; 5,599,346; 5,599,345; 5,486,161;5,472,441; 5,458,597; 5,536,267; 5,507,743; 4,486,196; 4,121,592; and4,016,886. See also, PCT Application WO 96/29946.

Electrosurgical instruments generally perform in either of twooperational modes, monopolar or bipolar. In the monopolar mode, electriccurrent is conducted between a relatively small active electrode and alarge return electrode located a distance from the active electrode.Because in the monopolar mode, current density in tissue decreases asthe square of the distance from the active electrode, it is moredifficult to treat more than very minimal volumes of targeted tissue aswell as to maintain the volumetric accuracy of such treatment.Notwithstanding such a surface related operational limitation, themonopolar devices are quite efficient as electrosurgical cutting toolsand for the purpose of carrying out a coagulation at the surface oftissue being cut. Each approach involves a different waveform but bothare surface related and involve arcing between the instrument tip andthe tissue being affected.

The bipolar mode of electrosurgical (joulean) heating involves passingcurrent between tissue disposed between two electrodes of similarsurface area. To effect cauterization of targeted tissue, thiselectrosurgical heating technique has been implemented with instrumentsthat deploy pointed, flexible fine wire or needle-likeelectrode-functioning stylets directly into the targeted tissue. Thiscalls for a mechanical system carrying out tissue penetration with thesefine deployed stylets which necessarily will have a small surface areaper unit length of the electrode. As a consequence, the permissiblecurrent flux flowing between the electrodes is significantly limitedinasmuch as excessive current densities will cause desiccation of tissueimmediately adjacent the electrodes which defeats the procedure. Thisfollows, inasmuch as the desiccated tissue adjacent the electrode willthen exhibit a very high electrical impedance which prevents furthertissue heating and thus limits the volume of tissue which can be treatedto the point of effective cauterization. For this reason, the fineneedle or stylet techniques heretofore employed have been observed torequire a treatment duration of ten to fifteen minutes for largerlesions. Further, a temperature monitoring of the fine electrode andeven the infusion of conductive fluids is called for to reduce impedancebetween the electrodes and surrounding tissue. Additionally, practicewith the needle extruding mechanisms have shown them to be difficult todeploy, the practitioner having less than desirable information as tothe exact positioning of the fine electrode stylets. For example, thesewires will deflect in the procedure of insertion into the targetedtissue in dependence upon their degree of flexibility as well as uponthe varying density characteristics of abnormal tissue sought to becauterized. Placement identification or observation procedures usingconventional imaging systems is hindered because of the highlydiminutive surface area of the electrodes themselves. In this regard,such imagining systems fail to “see” the electrodes. As a consequence,the targeted tissue is either under-treated or the treatment procedureextends cauterization excessively into adjacent healthy tissue, i.e., itencroaches excessively beyond the targeted tissue volume. Treatmentaccuracy again remains problematic. Bipolar mode electrosurgicalprocedures are described, for example, in U.S. Pat. Nos. 5,720,744;5,403,311; 5,122,137; 4,920,978; 4,919,138; and 4,821,725, while fineneedle electrode technologies are set forth, for example, in U.S. Pat.Nos. 5,470,309; 5,370,675; 5,421,819; 5,470,308; and 5,607,389.

Investigators also have looked to the destruction or control of tumor bythe devitalization or vascular interruption of oxygen and nutrientingress to targeted tissue volumes. Resultant cell death or necrosisagain may be accompanied by its physiologically natural absorption bythe body. As before, while this general approach to tumor managementholds promise, the practical aspects of control over the targeted tissuevolume using minimally invasive tactics has remained elusive. Seegenerally; Denekamp et al., “Vascular Occlusion and Tumor Cell Death,”Eur. J. Cancer and Clinical Oncology, Vol. 19 No. 2, pp 271-275 (1983).

As is essentially the case in all remotely guided procedures, theprocess for carrying out an incision, for example, of a volume oftargeted tissue is difficult. This difficulty is particularly inevidence where an incision is called for which does not invade thetargeted tissue volume, extending only about its periphery.

Highly controlled and accurate RF electrosurgical cutting promises toenjoy a number of surgical applications beyond topics such as vascularisolation of tissue volume. For example, rather basic intravascularcatheter guided monopolar electrodes have been employed as therapy for avariety of cardiac dysrhythmias. The therapy involves maneuvering of amonopolar electrode to sites of arrhythmogenic myocardium to carry outan ablation of heart muscle at discrete areas. While the therapy hasdemonstrated high therapeutic effectiveness, the treatment procedure issomewhat primitive, substantial volumes of tissue at the inner wall ofthe heart being destroyed until the aberrant conduction pathway iseliminated or blocked by the resultantly necrosed tissue. R. F. catheterablation techniques also have been used to treat ventriculartachycardias, atrial flutter, ectopic atrial tachycardia, and sinus nodereentry, albeit with lower success rates. These techniques are stillevolving and, as is apparent, a technique for accurately forming acontrolled linear lesion of known and minimal dimension will represent abeneficial advance in the therapy. See generally: Wood et al,Radiofrequency Catheter Ablation for the Management of CardiacTachyarrhythmias, Am J Med Sci 1993; 306(4):241-247.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to the system, apparatus and methodfor accurately cutting about and into tissue volumes withelectrosurgically deployed electrodes. The electrode employed with theinstrumentation is electrosurgically excited during the act of itsdeployment with respect to two, spaced apart support positions. By usingtwo such positions, the instrument design takes advantage of theinherent structural integrity of the arch. To implement this approach, athin, resilient elongate electrode is mounted within the forward endregion of a support member such that its distal end is fixed to theinstrument while it extends longitudinally rearwardly. Within theforward end region, the electrode extends within a deployment slot, thesides of which, in turn, extend between a forward location adjacent theinstrument tip and a rearward location. The sides of the deployment slotin combination with a compression-based mounting arrangement serve asstructurally supportive abutments to the arch formation developed as theelectrode is outwardly deployed by urging it forwardly into acompression stabilized arch. Control over the extent of deployment isprovided by the corresponding extent of the forward movement of theelectrode. Thus a highly stable compressed electrode arch configurationis developed with a repeatable and reliable profile which issubstantially immune from deformation which otherwise might occur duringthe carrying out of electrode cutting maneuvers pushing the sidewiseextent of the electrode through tissue.

The accuracy and repeatability achieved with the instant system hasimportant applicability to procedures for carrying out thecircumscriptive vascular isolation of a targeted tissue volume such as atumor. Because the arch shaped electrode is electrosurgically excitedfor cutting both during its deployment and retraction, a combination ofthose maneuvers with a relatively simple pivoting of the forward endregion of the instrument permits the devascularization of such tissue tooccur without the instrument touching that targeted tissue volumeitself. With the system, typically a volume of targeted tissue such astumor is isolated by a cut providing necrotic interfacing cut surfaceshaving a resultant circumscribing volume shape resembling a segment ofan orange. A desirable repeatability of the geometric pattern cut withthe system permits an iteration of the maneuvering procedure utilizingthe coagulating output of the associated electrosurgical generator.Thus, the devascularization or dearterialization of the targeted tissuevolume may be enhanced with beneficial elimination of any bleeding thatmight occur. Generally within minutes, the isolated targeted tissuevolume will begin to experience cell death and over a period of time,the natural functioning of the body may resorb it.

The accurate cutting achieved also permits the very accurate positioningor deposition of a barrier within the interface defined by thecircumscriptive cut carried out with the arch shaped electrodes. Suchbarriers will contribute to the assurance that the targeted tissuevolume is fully isolated from surrounding vital or healthy tissues to anextent beneficially restricting the rate of any neovascularization inaddition to the accurate positioning of barrier substances or fluids atthe noted cut interface. The structurally robust mounting of theelectrode configuration also permits it to draw a membranous barriershroud through the cut interface to carry out the noted additionalisolation of targeted tissue.

In the discourse to follow, the term “barrier” is referred to in thedescription of a variety of instrumentation embodiments. Such barriercomponents may be chemical agents functioning to slow down arevascularization process by increasing the depth of necrotic tissuewhich such neovascularization must span. Necrotising agents are selectedfor suitable localized administration and may include chemotherapeuticagents as well as alcohol and the like. The term “barrier” also is usedin a physical sense to function to slow down revascularization throughutilization of resorbable mesh or membranes, adhesives and variousanti-adhesion barriers. A variety of barrier agents and devices aredescribed in the discourse to follow.

The accuracy and stability of the electrode system also lends itsutility to the electrosurgical treatment of atrial flutter. In thisregard, rather than the relatively uncontrolled electrosurgical ablationprocedures currently practiced, the arch shaped electrode can beincorporated at the tip of an intravascular heart catheter forpositioning against the interior heart wall at a location transverselyintercepting the current path of that reentry current intended to beinterrupted. The electrode then is deployed while beingelectrosurgically excited to perform an accurate linear cut with cuttissue sides providing a necrotic tissue interface functioning tointerrupt the current path in avoidance of atrial flutter. In effect,treatment is achieved with substantially reduced damage to the heartwall.

Other objects of the invention will, in part, be obvious and will, inpart, appear hereinafter. The invention, accordingly, comprises themethod, system and apparatus possessing the construction, combination ofelements, arrangement of parts and steps that are exemplified in thefollowing detailed description.

For a fuller understanding of the nature and objects of the invention,reference should be made to the following detailed description taken inconnection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the system of theinvention;

FIG. 2 is a perspective view of the forward end region of an instrumentillustrated in FIG. 1:

FIGS. 3A-3E are schematic sectional views taken through the plane 3-3 inFIG. 2 and illustrating one sequence of vascular isolation maneuvers forthe instrument of FIG. 2;

FIG. 4 is a stylized graph showing an electrosurgical cutting waveformand a coagulation waveform output of an electrosurgical generator;

FIG. 5 is a perspective view of the forward end region of the instrumentshown in FIG. 1;

FIGS. 6A-6C are schematic sectional views taken through the plane 6-6 inFIG. 5 and illustrate another maneuvering arrangement of the instrumentof FIG. 5;

FIG. 7 is a partial sectional view of the front end region of theinstrument shown in FIG. 1 illustrating an electrode therein in aretracted orientation;

FIG. 8 is a sectional view taken through the plane 8-8 in FIG. 7;

FIG. 9 is a sectional view taken through the plane 9-9 in FIG. 7;

FIG. 10 is a sectional view taken through the plane 10-10 in FIG. 7;

FIG. 11 is a sectional view taken through the plane 11-11 in FIG. 7;

FIG. 12 is a sectional view of the front end region of the instrument ofFIG. 1 illustrating an electrode in a deployed orientation;

FIG. 13 is a partial sectional view of the base region of the instrumentshown in FIG. 1;

FIG. 14 is a sectional view taken through the plane 14-14 in FIG. 13;

FIG. 15 is an electrical block diagram of a control assembly employedwith the system of the invention;

FIG. 16 is a pictorial view of the forward end region of an instrumentaccording to the invention showing the presence of a surface mountedreturn electrode;

FIG. 17 is a partial sectional view of the forward end region of aninstrument according to the invention showing a dual electrodeconfiguration;

FIG. 18 is a pictorial representation of the forward end region of theinstrument of FIG. 17;

FIGS. 19A-19C are schematic sectional views taken through the plane19-19 in FIG. 18, showing maneuvering procedures carried out with theinstrument of FIG. 18;

FIG. 20 is a sectional view of the forward end region of an embodimentof the instrument of the invention showing an electrode deployment inphantom;

FIG. 21 is a sectional view taken through the plane 21-21 in FIG. 20;

FIG. 22 is a sectional view taken through the plane 22-22 in FIG. 20;

FIG. 23 is a sectional view taken through the plane 23-23 in FIG. 20;

FIG. 24 is a sectional view of the forward end region of anotherembodiment of the instrument of the invention showing a deployedelectrode in phantom;

FIG. 25 is a sectional view taken through the plane 25-25 in FIG. 24;

FIG. 26 is a sectional view taken through the plane 26-26 in FIG. 24;

FIG. 27 is a sectional view taken through the plane 27-27 in FIG. 24;

FIG. 28 is a sectional view of the forward end region of anotherembodiment of the instrument of the invention, showing a deployedelectrode in phantom;

FIG. 29 is a sectional view taken through the plane 29-29 in FIG. 28;

FIG. 30 is a sectional view taken through the plane 30-30 in FIG. 28;

FIG. 31 is a sectional view taken through the plane 31-31 in FIG. 28;

FIG. 32 is a sectional view taken through the plane 32-32 in FIG. 28;

FIG. 33 is a perspective view of the forward end region of anotherembodiment of the instrument according to the invention;

FIG. 34 is a partial sectional view taken through the plane 34-34 inFIG. 33;

FIGS. 35A-35E are partial and schematic sectional views taken throughthe plane 35-35 in FIG. 33 and showing a sequence of operationalmaneuvers that may be carried out with the instrument of FIG. 33;

FIG. 36 is a perspective view of the forward end region of anotherembodiment of the instrument of the invention;

FIG. 37 is a schematic sectional view taken through the plane 37-37shown in FIG. 36;

FIG. 38 is a partial sectional view of a base region of anotherembodiment of the instrument of the invention;

FIG. 39 is a partial sectional view of the base region of anotherembodiment of an instrument according to the invention;

FIG. 40 is a partial sectional view of the forward end region of theinstrument shown in FIG. 36;

FIG. 41 is a perspective view of the forward end region of anotherembodiment of an instrument according to the invention;

FIG. 42 is a sectional view taken through the plane 42-42 shown in FIG.41;

FIGS. 43A-43D are partial sectional views taken through the plane 43-43shown in FIG. 1 and schematically representing a sequence of operationalmaneuvers;

FIGS. 44A-44C combined as labeled thereon to provide a flowchart showingmethodology of the invention;

FIG. 45 is a schematic sectional view of a chamber of a heart showingthe positioning of a forward end region of another embodiment of aninstrument according to the invention;

FIG. 46 is a partial sectional view taken through the plane 46-46 inFIG. 45;

FIG. 47 is a flowchart showing methodology of the invention associatedwith the embodiment of the FIGS. 45 and 46;

FIG. 48 is a partial sectional view of the front end region of anotherembodiment of the instrument of the invention;

FIG. 49 is a sectional view taken through the plane 49-49 in FIG. 48;

FIG. 50 is a sectional view taken through the plane 50-50 in FIG. 48;and

FIG. 51 is a sectional view taken through the plane 51-51 in FIG. 48.

DETAILED DESCRIPTION OF THE INVENTION

The highly accurate and controllable electrosurgical cutting feature ofthe invention has particular applicability to minimally invasivesurgical procedures. Incisional accuracy is achieved with cuttingcomponents over which dimension is controlled during their manipulationand as a consequence of their structural stability. In the latterregard, the instruments employ the inherent structural integrity of thearch. Such two position support of fine cutting electrodes permitssurgical cutting procedures to be carried out within an advantageouslyshorter interval of time. In one modality of its use, a small tumor, forexample, having a diameter of less than about one-half centimeter whichhas been discerned for example, by mammography and/or ultrasonography,is not subject to conventional biopsy procedures. Such tumors orabnormalities, for 80% of their occurrences, will be benign. Where abiopsy procedure, for example, needle biopsy is employed, where thetumor is malignant, seeding risks are present. With the presentapproach, the periphery of the tumor or abnormality is accessed with afine wire-like instrument and by employing electrosurgical cutting, thesmall abnormal region is vascularly isolated. In particular, thedearterialization occurring with such isolation induces complete celldeath throughout the interior of the circumscribed volume within hoursdue to lack of oxygen and nutrients. Subsequently, over a period oftime, the body may resorb the dead tissue. The diminutiveinstrumentation employed for this procedure is relatively inexpensivewhen compared with conventional biopsy procedures and is quite minimallyinvasive. To assure effective devascularization, a surface coagulationor preferential surface deposition of electrical heating additionallycan be carried out either as a subsequent step or utilizing a “blend”waveform simultaneously accomplishing both electrosurgical cutting andsurface coagulation. Another approach to assuring devascularizationprovides for the formation of a barrier layer at the interface of anelectrosurgical cut. This layer may be in fluid or membranous form.

Referring to FIG. 1, one embodiment of the apparatus and system forcarrying out the vascular isolation modality of the invention isrepresented generally at 10. System 10 includes a customizedelectrosurgical generator and control arrangement represented generallyat 12. The assembly 12, has a forward panel 14 at the lower level ofwhich are provided three connector receiving receptacles 16, 17 and 18.Above the latter two receptacles is a paper strip 20 extending outwardlythrough a slot behind which is positioned a printer assembly (notshown). Visual cueing through the media of selectively energized lightemitting diodes (LED) is provided at panel 14 as represented at 22-25.Finally, rearwardly upon the generator assembly 12 is an audio grill 28through which aural cueing signals are broadcast.

A control assembly cable 32, having a connector 34 is shown extendingfrom an electrical connection with receptacle 18. The instrument orelectrosurgical cutting apparatus of the invention is representedgenerally at 40. Instrument 40 is seen to include an elongate supportmember represented generally at 42 which extends between a tip 44 and abase or rear region 46. Base region 46, for the instant embodiment, isconfigured to attach to a removable handle for manual positioning of theinstrument 40. In this regard, the support member 42 and associatedcomponents may be a disposable item, while the handle 48 and itsassociated components may be sterilizable or disinfected and reusable.Located inwardly from the tip 44 is a forward end region 50 whichextends along a longitudinal axis 52 from the tip 44 and, during aninsertion mode of operation, the forward end region 50 of the instrument40 is positioned in adjacency with the peripheral extent of the tissuevolume to be vascularly isolated by circumscription. In this regard, thetip 44 and support member 42 are not inserted into the target tissuevolume but into normal or healthy and viable tissue immediately next tothe peripheral extent of the volume of targeted abnormal tissue.

Seen extending outwardly from a deployment portion of the forward endregion 50 is a thin, resilient electrode 54 having an arch shapedconfiguration. During the positioning into or removal of the instrument40 from the tissue, the electrode 54 is retracted into a nestedorientation within a deployment portion of forward end region 50.Actuation of electrode 54 to its deployed orientation, as well asretraction therefrom for the instant embodiment is by an actuatorassembly represented generally at 56.

Handle 48 is seen to support control button-type switches 58 and 60.Such switches are used to activate electrode 54 with, for example,surgical cutting current, a coagulation dedicated current or a blend ofthose two currents. As an alternate or supplementary arrangement, moreremote switching may be provided. In this regard, a connector assemblycable 62 is shown having a connector 64 inserted in electricalcommunication with the receptacle 16 of generator assembly 12. Cable 62extends to a foot pedal-type dual switch represented generally at 66 andhaving foot actuated switches 68 and 70.

Returning to the handle component 48, visual cueing devices such aslight emitting diodes (LED) also may be provided as represented ingeneral at 72. Electrode 54 operates in a monopolar fashion duringperformance carrying out electrosurgical cutting and for coagulationpurposes. To provide a return for this form of cutting, a conventionalremote patient return electrode is provided as shown at 74. Electrode74, having an extended surface area, is applied to a surface of thepatient's body and is seen connected to electrosurgical generator 12 bya cable 76 extending to a connector 78 which, in turn, is operativelyinserted within the receptacle 17.

Upon power-up of the electrosurgical generator assembly 12, a componentof the control thereof carries out a form of electrical interrogation ofthe instrument 40. In this regard, the electrosurgical cutting currentwaveform will vary in terms of peak-to-peak voltages within a range ofabout 500 to 3500 volts. This variance will depend upon the principalcross-sectional dimension or shape of the wire-shaped electrode 54. Ineffect, the electrosurgical cutting involves a highly concentrated orlocalized energy deposition and associated heating of tissue tosufficient levels to effect vaporization of cellular fluid. This causesthe rupture of cell walls to carry out a “cut”. An optimum coagulationwaveform, on the other hand, is configured not to cut but to depositelectrical energy preferentially on the surface of the tissue. Whilecoagulation waveforms exhibit a relatively higher crest factor, they areconfigured with a relatively high but short pulse followed by a dampedwaveform. A blend performance carried out by the assembly 12 combinesthe sinusoidal electrosurgical cutting waveform with the coagulationwaveform. In general, the size and ultimate arch apex value of theelectrode 54 will vary in accordance with the targeted tissue size. Forthe most part, that size will be quite small, i.e., less than about 2 cmin diametric extent. Accordingly, a desirable aspect of the invention isto provide an electrical parameter based code within the instrument 40which is interrogated by the control system associated with thegenerator 12. Upon the interrogation of that code component, forexample, LED 22 is energized to represent that the system is ready. Thenthe forward end region 50 of the instrument 40 is positioned within thepatient adjacent the peripheral extent or boundary of the volume oftargeted tissue. By depressing either foot pedal 68 of switch 66, oractuating the switch 58 on handle 48, the electrosurgical cuttingprocedure is initiated. As this occurs, the control within generator 12energizes LED 23 to indicate an “energization” status and a distinctaudible tone of an initial first frequency, for example, in the range of800 to 1000 Hz, is generated and broadcast through the grill 28. Thepractitioner then actuates the instrument 40 at actuator assembly 56 tocause a gradual deployment of the electrode 54 from its nested originalinsertion mode orientation. The practitioner then manipulates theinstrument 40 including the actuator control 56 to carry out acircumscriptive vascular isolation of the targeted tissue volume byelectrosurgically cutting about its periphery with a procedure ofoutward electrode deployment, pivoting, and electrode retraction whilecutting. Accordingly, the selection of the size of electrode 54, and ineffect, support portion 42 generally is predicated upon the size of thetargeted tissue at hand.

Turning to FIG. 2, the forward end region 50 of instrument 40 is shownat a higher level of detail. In FIG. 2, electrode 54 is seen deployed asa thin, resilient wire that has been extended as an arch from anoutwardly open deployment portion or slot 80. The slot 80 extends from aforward location 82 to a rearward location 84 and adjacent to thoseforward and rearward locations, the electrode 54 is seen to be insulatedby respective insulative flexible tubes or sleeves 86 and 88. Thesesleeves 86 and 88, in conjunction with the slot surface form two, spacedapart abutments for structurally supporting the electrode arch. Thisarch structurally develops the strength and thus, dimensional integritynecessary for a pivoting, arc-defining locus of cutting movement towhich the electrode 54 is subjected. Electrode 54 is deployed from itsretracted, nested position within slot 80 by urging it forwardly incompression to effect outward movement generally transversely to thelongitudinal axis 52 to an extent curving it into an outwardly dependingarch formation as shown. During this procedure, electrosurgical cuttingcurrent is applied to the electrode so that it, in effect “cuts” its wayinto a deployed orientation. This same cutting activity is continuedduring a manipulation of the instrument 50 and the electrode 54 bypivoting or rotation as represented at curved arrow 90 aboutlongitudinal axis 52 and by retraction of the electrode 54 to selectlocation to vascularly isolate the volume of targeted tissue. A fullcircumscription of such tissue is achieved with the continuous electrode54 as is represented in the maneuvering diagram set forth in FIGS.3A-3E.

Looking to FIG. 3A, a section through forward end region 50 is shown asit intersects the electrode 54 at the apex of the arch defined by itupon being fully deployed. In the figure, the electrode 54 apex locationis shown with that same numeration. The figure further reveals the slot80, as well as a section of a deflector guide component 92. Electrode 54is shown having been deployed to an apex radius R1 and having completedan electrosurgical cut to that radial extent as represented by the cutindicator line 94. This cut line 94 will reside in healthy tissue but inadjacency with the targeted tissue volume 102 peripheral extent. Tocarry out a circumscription of such tissue, instrument forward endregion 50 will have been oriented angularly as shown and indicated bythe angular designation θ=0. The deployment of electrode 54 is such thatits apex will pass over the “top” of the targeted tissue 102. Looking toFIG. 3B, the fully deployed electrode 54 continues to be energized fromits angular location θ=0 and the instrument forward end region 50 ispivoted about axis 52 to describe the arc-shaped cut surface representedat cut indicator line 96, the electrode 54 now being at an angularposition θ=θ1 and at the continuing outer radius, R1. At this position,the electrode 54 will have cut over the targeted tissue volume 102 andwill reside in adjacency with an opposite side of it. Looking to FIG.3C, while the forward end region 50 is at the angular orientation θ=θ1,it is retracted toward the deployment portion 80 while carrying outelectrosurgical cutting as represented by the cut indicator line 98.Retraction is halted, however, before electrode 54 becomes fully nestedwithin the slot 80. At this location, the electrode will be withinhealthy tissue and adjacent the last or fourth side of the targetedtissue volume 102. As represented in the figure, its location radiallyis identified at R2 while its angular orientation remains at θ1.

The next maneuver is represented in FIG. 3D where, while remaining atthe radial distance R2, electrode 54 is rotated or pivoted at theforward end region 50 from the angular orientation θ=θ1 to the initialangular orientation θ=0, full circumscriptive vascular isolation havingbeen accomplished with the final cut represented at cut indicator line100. The volume represented by such an electrosurgical cutting procedurewill resemble a segment of an orange. Note in the figure that electrode54 now is poised at the cut indicator line 94 and radially positionedabove the slot 80. FIG. 3E reveals the final retraction of electrode 54into the slot 80 in preparation for removal of the instrument 40 forwardend region from its position of adjacency with the targeted volume oftissue. That tissue, having been vascularly isolated, will exhibit celldeath within hours and ultimately may be resorbed into the body.Advantageously, the steam (i.e, boiled cellular water) generated duringthe maneuver illustrated in FIGS. 3A through 3E escapes along theinterface between the cylindrical surface 120 of instrument 40,effecting heating and cauterization of tissue adjacent that cylindricalsurface 120, thereby further minimizing the possibility of needle-trackmetastasis.

The practitioner is afforded additional options in connection with theinstant procedure. In this regard, the locus of cutting activity of theelectrode 54 may be reiterated while carrying out a coagulation of thetissue immediately adjacent the electrosurgically defined cut, i.e., atthe cut tissue interface. Alternately, the cut itself may be made with ablend mode of operation of the electrosurgical generator 12 such that acutting activity is combined with a coagulation activity. Additionally,the instrument 40 may be configured to express a cauterizing fluid, abarrier fluid or deploy a barrier shroud at the tissue interfacerepresented by the cut indicator lines 94, 96, 98 and 100. Such anaddition to the procedure inhibits the rate of any revascularization ofadjacent cut tissue surfaces. It may be observed, however, that theelectrosurgical cutting approach is one developing necrotic surfacecharacteristics that inhibit or slows such revascularization.

Looking momentarily to FIG. 4, (below FIG. 14), a sinusoidal form ofcurve 110 is schematically illustrated with the purpose of describing aconventional electrosurgical cutting waveform. Because of thiscontinuous waveform, a sustained arc is developed causing theabove-noted intense localized heating and cell rupture at the point ofimpingement of the arc. This develops a cutting effect. Often, the goodcutting achieved with waveforms as at 110 is accompanied by somebleeding in conventional electrosurgical approaches. The generators asat 12 then are provided with a coagulation mode of operation that isrepresented in the figure at 112. Note that this is a highly dampedwaveform with high peak-to-peak voltage excursions for short intervals.This waveform is not a cutting system but provides a preferentialsurface deposition of electrical heating to cause localized coagulation.The noted blend operation combines the outputs represented at 110 and112.

A substantial application of the instant system is involved with tumoror abnormal tissue encountered in the breast. For the present system,where such tumor is quite small, for example, less than about 1 cm indiameter and more often, having a diametric extent of only a fewmillimeters, then an abbreviation of the procedural manipulationrepresented in 3A-3E becomes available to the surgeon. Looking to FIG.5, the forward end region 50 of the instrument 40 is represented in thesame manner as shown in FIG. 2 but with a section noted at 6-6. Themanipulation of the instrument forward end region 50 for thisabbreviated procedure is represented in conjunction with FIGS. 6A-6C.Looking to FIG. 6A, following the positioning of forward end region 50into adjacency with one side of the targeted tissue volume 104, anangular orientation represented at θ=0, the electrode 54 is deployed toform an arch while being excited with electrosurgical cutting current.The resulting cut indicator line through healthy tissue but in adjacencywith the targeted tissue volume 104 is represented at 114 extending tothe radial distance R1 representing the radius at the apex of the archconfiguration of the electrode 54. Next, as represented in FIG. 6B, theforward end region 50 is rotated about longitudinal axis 52 through theangular orientation θ=θ1 to describe a cutting surface locus representedat cut indicator line 116 which extends over or about a top side of thetargeted tissue 104 peripheral extent. At the completion of thatmaneuver, the angular position θ=θ1 is reached. FIG. 6C shows thatfollowing the completion of the cutting of surface 116, electrode 54 isfully retracted while being excited for electrosurgical cutting asrepresented by cut indicator line 118. Retraction is into a fully nestedorientation within the deployment portion or slot 80. However, thatcylindrical surface 120 of the forward end region 50 will have severedthe very small amount of tissue in adjacency therewith, particularly,with the rotation of the region 50. In general, this will be sufficientfor evoking vascular isolation and consequent cell death. Of course, anecrotizing fluid, barrier fluid or sheath also may be employed withthis abbreviated procedure. Following the retraction of electrode 54 toits nested orientation within deployment portion or slot 80, the forwardend region 50 is removed from its position of adjacency with thetargeted tissue.

Referring to FIG. 7, (above FIG. 12), a sectional view of the forwardend region 50 of instrument 40 is revealed. In the figure, the tip 44 isshown to be configured having an annular shoulder 122 that is insertedwithin the forward end of the tubular support member or cannula 42. Tip44 is seen to be configured as a trocar for purposes of penetration(percutaneous) through the patient's tissue. Positioned immediatelyrearwardly of the tip 44 is a cylindrical, electrically insulativeelectrode engagement block 124 having a rearwardly facing cylindricalopening therein 126 which adhesively receives both the electrode 54 andassociated electrically insulative sleeve 86.

Referring additionally to FIG. 8, a sectional view reveals the profileof the above-noted electrode engagement block 124 along with the opening126 formed therein. Additionally, a sectional view of electrode 54 andinsulative sleeve 86 is revealed.

Returning to FIG. 7, the electrode 54 is depicted in its retracted ornested orientation as is utilized during an insertion mode whereininstrument 40 is moved into adjacency with the volume of targetedtissue. This orientation also is employed in a removal mode wherein theinstrument 40 is removed following a vascular isolation procedure. Thefigure further reveals the generally cylindrical deflector guidecomponent 92 which functions to support electrode 54, as well as toprovide an outward bias thereof at the commencement of its deployment.Shown extending within the guide component 92 is a tubular shaped fluidconduit 128 that has a fluid outlet 130 located within the deploymentportion or slot 80. Outlet 130 is located such that a barrier fluiddelivered from conduit 128 may be expressed therefrom and into contactwith adjacently disposed electrosurgically cut tissue surfaces.

Looking additionally to FIG. 9, a sectional view of the support member42 at the position of deflector guide component 92 is revealed. It maybe observed that the deployment portion or slot 80 at component 92 isconfigured as an inwardly rounded truncated trapezoidal elongate notchformed within component 124. FIG. 9 also reveals a cross section of thebarrier fluid delivery channel 128. The support member 42 is shown ashaving an outer diameter, D₁. Returning to FIG. 7, electrode 54 is seento extend rearwardly, whereupon it is slidably engaged by electricallyinsulative sleeve 88 which, in turn, is fixed within a cylindricalcavity 132. Cavity 132 extends rearwardly from the outer face 134 of acylindrical, electrically insulative electrode guide and conduit support136. Guide 136 is configured having a channel or lumen 138 through whichthe electrode 154 may slide. Being fixed within the interior 140 ofsupport 42, the guide 136 additionally is formed having a cylindricalchannel 142 for supporting the fluid conduit 128.

Looking momentarily to FIG. 10, a sectional view of the above featuresadjacent face 134 of electrode guide 136 is provided. In the figure, itmay be seen that the flexible insulative sleeve 88 is fixed within thecylindrical cavity 132 and that the electrode 54 is slidable withinsleeve 88 as well as within the channel or lumen 138. The figure alsoreveals that the channel 142 is in supporting relationship with theconduit 128.

Looking to FIG. 11, a sectional view taken just rearwardly of thesection represented at FIG. 10 is portrayed. In this figure, the channelor lumen 138 extending through the electrode guide 136 is revealed.Slidability of electrode 54 through the channel 138 is evidenced by theannular gap 144 extending therebetween. The figure also shows theearlier noted support of the fluid conduit 128 by channel 142.

Looking to FIGS. 7 and 12, the operation of the electrode deploymentsystem is illustrated. In general, the electrode 54 may be constructedof an electrically conductive material such as tungsten, molybdenum,niobium, columbium, tantalum, vanadium, titanium, nickel, cobalt, iron,platinum, zirconium, copper, alloys containing one or more of theabove-listed metals, stainless steel, or electrically conductivepolymers or plastic. Electrode 52 is deployed by utilizing an actuatorassembly to mechanically urge it forwardly in compression against itsforward connection as at 128 in block 124. As this compressive movementoccurs, electrode 54 is constrained from transverse movement at alllocations except at the electrode deployment portion or slot as at 80.Thus, the electrode 54 will tend to distort outwardly to form anarch-like structure, in effect moving outwardly transversely to thelongitudinal axis 52. To assure that the transverse movement isoutwardly, for the instant embodiment, the deflector guide component 92provides a preliminary outward deflection or bias upon the electrode 54.Looking to FIG. 12, electrode 54 is shown in phantom at its insertionand removal mode nested orientation, and having been moved to an outwardarch defining positioning as represented at 54′. The insulating functionof insulative sleeves 86 and 88 becomes apparent from the figure. Theextent of outward deployment is dependent upon the corresponding extentof forward movement of the electrode component 54. In this regard, theelectrode 54 is actuated to move forwardly an “arch defining distance”.For most applications of the instant system, this will be a distancerepresenting a maximum deployment of the apex of the arch, asrepresented in conjunction with the radius R1 discussed above. It may beobserved that an important structural integrity of the deployedelectrode 54′ is achieved with the present instrument design. A wirearch in compression has been formed between two laterally supportiveabutments adjacent the spaced apart forward location 82 and rearwardlocation 84. The side surfaces of slot 80 achieve such lateral support.Thus enhanced lateral pressure on the deployed electrode 54′ may beimposed by the practitioner during the rotational or pivotal maneuverdescribed in conjunction with FIGS. 3B, 3D, and 6B without distortingthe arch shape. This feature beneficially shortens the length of timerequired for the cutting procedure and enhances the predictability ofthe volume circumscribed. FIG. 12 also reveals symbolically, theexpression of barrier fluid from the fluid outlet 130 as represented at146. Such a barrier supplements any barrier effect afforded by the layerof thermal necrosis induced as a result of the electrosurgical cuttingprocess. Thus the rate of neovascularation is further retarded. Barrierfluids may be provided as tissue sealants or glues and/or necrotizingagents. In this regard, fluids such as ethyl alcohol, ferric hyaluronategel or N, O-carboxymethyl chitosan gel or solution may be utilized.

Referring to FIG. 13, base or rear region 46 of the instrument 40 isrevealed in sectional detail as it is coupled with the support member42. Looking to the figure, support member 42 is seen to be connectedwith the cylindrical forward housing 150 at a centrally disposedcylindrical opening 152. Cylindrical opening 152 extends from a circularforward face 154 to an interior cavity 156. The rearward end of supportmember 42 is seen to abut against a shoulder 158 formed within theopening 152. Stationary electrode guide 136 is seen to extend to thebase region 46, having a rearward face 160. Shown extending through theelectrode guide 136 is the earlier described channel or lumen 138 withinwhich electrode 54 is slidably disposed. Stationary guide 138 functionsto slidably retain electrode 54 and restrain it for longitudinalmovement only.

Mounted into the rearward face 160 of electrode guide 136 is a tubular,rigid insulative support sleeve 162. Slidably retaining electrode 54,the sleeve 162 extends in cantilever fashion rearwardly into slidableinsertion within an electrode drive block 164. In this regard, a channelor lumen 166 within the block 164 slidably receives sleeve 162. Notethat sleeve 162 is seen to end or terminate at 168. However, electrode54 extends beyond the termination point 168 within channel 166 to therear face 170 of electrode drive block 164. Block 164 is formed of aninsulative material and electrode 54 is seen to be attached to the blockat its rear face 170 as seen at union 172. Attachment may be by anelectrically conductive adhesive or solder. Also electrically coupled toelectrode 54 at the union 172 is a flexible electrical lead 174. Lead174 is configured in a loosely extended fashion to provide “slack” topermit its forward translation upon the actuation of the electrodesystem.

Electrode drive block 164 is slidably mounted within the rearward cavity176 of support member 42 and its position is controlled by thepractitioner. In this regard, advancement or retraction of the driveblock 164 is carried out by rotating a cylindrical control knob 178 inone direction or another to carry out deployment or retraction ofelectrode 54. Knob 178 is formed having a cylindrical bearing surface180 which is slidably positioned over the outer surface of supportmember 42. At the location of this mounting, a helical slot 182 extendsthrough and winds about support member 42. Extending through this slot182 is a slot tracking pin 184 which is mounted radially within the knob178. The inward end of tracking pin 184 slidably engages a rectangularannular groove 186 formed rearwardly within the electrode drive block164. Spring mounted for outward bias within the slot tracking pin 184 isan expansion or detent member 188. With the arrangement shown,practitioner rotation of knob 178 will cause translational movement tooccur with respect to both knob 178 and block 164 either in a forwardlyactuating direction or a retraction direction. This occurs as the pin184 tracks within helical slot 182. The resultant movement of block 164drives electrode 54 forwardly or rearwardly. A maximum forward movementof knob 178 is represented in phantom at 178′. In effect, thistranslational movement amounts to the earlier-described “arch definingdistance”. To facilitate the positioning of knob 178 at intermediate orincremental locations along the track of the helical slot 182, groovesas at 190-193 are formed within the slot 182. These grooves 190-193 arereleasably engagable by the detent member 188. Further stability ofpositioning may be provided by locating an annular slot as at 196 withinthe knob 178 extending outwardly from the cylindrical bearing surface180. Within that slot there is positioned an O-ring 198. The frictionalengagement of the O-ring 198 with the outer surface of support member 42will enhance the stability of positioning of knob 178 and, inconsequence, the positioning of electrode 54.

As discussed above, during the deployment, physical movement andretraction of electrode 54 an electrosurgical cutting defined currentand voltage may be applied to it from lead 174. Additionally, during aniteration of that procedure, a coagulating voltage and current waveformmay be applied from that lead. Also, an earlier noted “blend” of thesetwo waveforms may be applied from that lead.

The leads within cavity 156 extend to an array of connector pins 200which extend from their mounting within a connector mounting block 202.Three of these connector pins of the array 200 are seen in FIG. 13. Inthis regard, pin 204 supplies electrosurgically cutting defined currentand voltage or the noted “blend” output. Correspondingly, pin 206provides a current and voltage intended for coagulation. Note thatconnector 204 is electrically coupled with connector 206 by a jumper208. Pin 206 additionally is coupled via earlier described line 174 toelectrode 54. Thus, with appropriate control logic evoked from thecontrol features of the electrosurgical generator assembly 12, connectorpin 206 is open circuited during electrosurgical cutting performancewith current delivery emanating from connector pin 204. Conversely,connector pin 204 is open circuited during coagulation voltage andcurrent delivery from pin 206. An optional connector pin within thearray 200 is shown at 210. As shown by a flexible lead 212 which iselectrically connected to the support member 42, this connection may beused to apply electrosurgical return to the support member 42 either atthe location shown or more forwardly, for example, at a discrete returnor additional electrode adjacent the forward end region 50.

Handle 48 is removably coupled to the assembly including housing 150 andconnector pin block 202 and extends rearwardly from the rearward face214 of block 202. With the opposite sides of the connector pin array 200extending through face 214 and with housing 160 extending as an openright cylinder at wall portion 216, a male socket arrangement is evoked.Thus, the instrument 40 can be plugged into the mating female socket ofhandle 48 for connection to the generator and control assembly 12 viacable 32 (FIG. 1). Accordingly, the hand manipulable handle 48 may beprovided for use with any of the variety of instruments 40. The handlecomponent 48 is necked down at 218 to be insertable within thecylindrical receptive cavity defined by wall portion 216. Necked downportion 218 is connected with a cylindrical receptacle support block 220which contains an array of electrical pin receptors shown at 222. Thesereceptors correspond with the connector pins of array 200. Of the pinreceptors shown, pin receptor 224 provides connection with pin 210 andfunctions to couple electrical return from lead 226. Pin receptor 228functions to provide monopolar electrosurgical cutting current andvoltage or a “blend” output and is seen connected with input lead 230.Finally, pin receptor 232 conveys coagulating current and voltage frominput lead 234. Pin receptors of the array 222 extend forwardly to theforward face 236 of pin receptacle support block 220 to provide forconnection with the corresponding connector pins of array 200.

To provide a form of automatic adjustment of the electrosurgicalgenerator control with respect to the type of electrode deployed andelectrical parameters desired, the connector pins at array 200 may beemployed for coding purposes. Such additional control functions areshown in FIG. 14 in conjunction with the earlier described pinconnectors of array 200. In that figure, connector pins 238 and 240 areprovided in circuit connection with an electrical coding element 242.Element 242 may be, for example, a resistor, capacitor or inductor whichis interrogated from the control system at generator and controlarrangement 12 to identify voltage and/or current settings and limitsfor electrosurgical tissue cutting procedures, particularlycorresponding with the functional physical characteristics of theelectrode involved as at 54.

Returning momentarily to FIG. 13, barrier fluid conveying conduit 128 isseen to extend into cavity 176 and protrude through the wall of supportmember 42. As it protrudes therefrom, it is connected to a fitment 250,for example, of a variety suited for connection with a conventionalhypodermic syringe that will carry barrier fluid. Thus, the syringerepresents a form of fluid reservoir wherein the fluid can be manuallypressurized for conveyance along conduit 128 and expression at the fluidoutlet 130 (FIG. 12). Fluid delivery conduit 128 may be formed, forexample, of stainless steel or silicone.

The figure also, in cooperation with FIG. 12 identifies a dimension, L₄representing a length of the entire support portion

Referring to FIG. 15, a block schematic representation of the surgicalgenerator and associated control assembly of the system 10 is portrayed.In general, this latter feature of the system functions to decode thecode carrying electrical parameters within the instrument 40. Then,responding to switch actuation from the practitioner, the generatorfunction supplies a monopolar radiofrequency (RF) electrosurgicalcutting current to the electrode 54 of instrument 40. As is discussed inconnection with FIGS. 3A-3E and 6A-6C, this cutting activity ensues bothduring deployment of electrode 54, manipulation thereof, for example, bypivoting and during a retraction of it in order to vascularly isolatethe targeted tissue. The cutting manipulative procedure with electrode54 may be reiterated in conjunction with the application of acoagulative current and voltage and, optionally, the cutting current andcoagulating current may be combined.

Looking to the figure, a radiofrequency (RF) cutting current and “blend”output electrosurgical generator function is represented at block 252,while a radiofrequency (RF) coagulation current electrosurgicalgenerator is represented at block 254. Earlier described connectorreceiving receptacle 16 reappears schematically in conjunction withcable 62 and connector 64 extending from the foot pedal switch 66.Similarly, connector receiving receptacle 17 reappears in connectionwith connector 78 and cable 76 which extends to the remote patientreturn 74 (FIG. 1). Cable 32 extending from the handle portion 48, ascoupled with the instrument 40, reappears in connection with themulti-pin connector 34 and multi-pin connector-receiving receptaclerepresented generally at 18.

Inputs and outputs associated with the connector 34 are shown inconnection with a terminal block 256. The inputs and outputs at terminalblock 256 are those associated with the connector pins described inconnection with FIG. 14. Accordingly, each of the connector locations atterminal block 256 is identified by the numerical identification of theconnector pins set forth in FIG. 14 but in primed fashion. Additionally,the connector block 256 includes generalized representations forinterface functions contained on the handle component 48 itself. In thisregard, terminal 258 is electrically associated with switch 58 shown inFIG. 1, which signals the control system to commence electrosurgicalcutting operation or “blend” performance in similar fashion as switch 68of foot pedal switch 66. Terminal 259 is operationally designated withrespect to switch 60 at handle 48 and provides for the generation of acoagulation current defined output. Terminal 260 is designated for thepurpose of energizing one LED at array 72 upon handle 48 thatcorresponds with the “energized” output at LED 23 of generator assembly12. The terminals 258-260 are associated with a control logic circuit262 via respective arrows 264-266. In similar fashion, the outputs ofswitches 68 and 70 of the foot pedal switch assembly 66 are introducedto the control logic circuit 262 via arrow 268.

Upon being powered-up via a power-on switch (not shown), control logiccircuit 262 carries out a sequence of procedures in anticipation of theswitch actuations to be performed by the practitioner. As represented byrespective arrows 270 and 272, the control logic circuit, inter alia,carries out control over the activation of the RF electrosurgicalcutting/blend generator 252 and the RF electrosurgical coagulationgenerator 254. However, as a condition precedent to the outputting ofthe initially utilized electrosurgical cutting current from generator252, the control logic circuit 262 responds to the selection signalinput of a decoding circuit as represented at arrow 274 and block 276.Decoding circuit 276, in turn, is seen responding via leads 278 and 280to the decoding electrical parameter condition developed via terminals238′ and 240′. This represents an interrogation of coding element 242 asdescribed in connection with FIG. 14. Following carrying out of aperformance configuration of the cutting electrosurgical generator 252with respect to the input from decoding circuit 276, control circuit 262activates the display function represented at block 282 as representedby arrow 284. Display 282 provides an aural cueing as described earlieras well as an activation of the LED at 22 representing a “system ready”condition. LED 25 is illuminated during the above-noted decodingprocedure. Logic circuit 262 then, as represented at arrow 286, appliesa control signal to a solid state switching network represented at block288. This provides for the closure of switch functions symbolicallyrepresented at S1 and S2 which couple respective output and return lines290 and 292 with respective lines 294 and 296 extending to the primaryinput of an isolation transformer 298. Transformer 298 is employed toisolate the patient from the radiofrequency generator and control system12, as well as to isolate the RF cutting source 252 from the coagulationsource 254. The output from the secondary winding of transformer 298 isprovided at lines 300 and 302 and is directed to the input of a highpass filter represented at block 304. Filter 304 further reduces theamplitude of lower frequency signals, for example, frequencies belowabout 20 kHz that can otherwise lead to unwanted stimulation of nervesand/or muscle tissues within the patients' body. For example,interference is possible with natural or imposed pacing signals withinthe heart. The return component of the circuit, upon exiting high passfilter 304, is coupled, as represented at line 306 with the remotepatient return as at 74 (FIG. 1) via receptacle 17. Correspondingly, theoutput from high pass filter 304 is directed, as represented at line 308to terminal 204′ and thence via cable 32 to connector pin 204 forconduction via jumper 208 and lead 174 to electrode 54 (FIG. 13). Asthis current and voltage waveform is applied, the practitioner will turnthe control knob 178 and provide for the deployment of electrode 54 asdescribed in connection with FIGS. 3A-3E and 6A-6C. As discussed inconjunction with FIG. 13, in connection with connector pin 210, as analternative, the return may be developed from a return electrodesupported at support member 42. This electrical association isrepresented at dashed line 310.

Upon completing a circumscriptive cutting procedure as discussed inconjunction with FIGS. 3A-3E and 6A-6C, the practitioner then releasesthe switch 58 or 68 which had been depressed to carry out that function.Then, for the reiterative coagulation procedure, either of switches 60or 70 are closed to cause the coagulation mode of operation. With suchclosure, control logic circuit 262 responds by activating the displayfunction 282 to provide an aural clue as earlier described, as well asto illuminate the LED 24 as seen in FIG. 1 and an appropriate LED at thehandle 48. RF coagulation electrosurgical generator 254 then isactivated with the generation of a signal, as represented at arrow 286and block 288, closing switches symbolically represented as S3 and S4.Such closure couples lines 312 and 314 with corresponding lines 316 and318 which are directed to the primary winding of an isolationtransformer 320. Transformer 320 provides the isolation features earlierdescribed in connection with transformer 298. The return component ofthe secondary output of isolation transformer 320 is coupled via line322 to the electrosurgical return function at line 306 extending, inturn, to connector 17. As before, as an alternative, an on instrumentreturn can be utilized as represented at dashed line 310. The secondoutput from the secondary of isolation transformer 320 is provided atline 324 which extends to the input of a high pass filter 326 whichserves the same function as filter 304. From the filtering function 326,voltage and current are provided at line 328 which, in turn, extends toterminal 206′. As illustrated in connection with FIG. 13, terminal 206′is electrically associated via cable 32 and associated lead 234,receptor pin 232, pin 206 and lead 174 extending to electrode 54.

Support member 42 may be formed from a variety of materials,particularly depending upon its implementation. In this regard, it maybe rigid as shown in the embodiments thus far described. Additionally,the electrosurgical cutting approach may be employed with a flexiblesupport such as a catheter. Such flexible components may be deliveredthrough a guide tube or may be steerable and employed with devicessimilar to flexible intravascular and endoscopic systems. Materialswhich may employed in forming in the support member may be, for example,metals such as stainless steel, elastomeric materials or inorganicmaterials such as ceramic, glass/ceramic or glass, unfilled plastic orfilled plastic or fiber-reinforced composites such as a pultrusion,marketed by Polygon Company of Walkerton, Ind. For purposes ofaccurately positioning it with respect to targeted tissue volume, theforward end region or working end 50 may incorporate a coating, coveringor component that enhances its image contrast. For example, coverings orcomponents may be used as radiography markers, in which case, a platinumband may be positioned about the surface of the component. Additionally,an ultrasound contrast agent such as a coating of hollow microspheresmay be positioned at that region. While the most prevalent use of theinstrument 40 will be in conjunction with substantially small targetedtissue volumes, the size of targeted tissue may vary substantially andthe dimension of certain components of instrument 40 may fall with arange of values. In the foregoing figures, these variable dimensionshave been graphically identified as L₁-L₅., D₁ and D₂. The dimensionsL_(x) are described in connection with FIG. 12 and, more particularly,with respect to L₄ in conjunction with FIGS. 12 and 13, the latterfigure showing the terminus of that dimension at the retractedorientation of the actuator assembly 56. The ranges for the abovegeometric parameters are set forth in the following tabulation (alldimensions being in inches):

Size Range Preferred Most Preferred D₁ 0.020-0.50  0.030-0.25 0.040-0.20D₂ (cutting electrode) 0.005-0.050  0.008-0.040 0.010-0.02 L₁ 0.15 to5.5 0.30 to 4.5 0.40 to 3.5 L₂  0.05 to 1.50 0.080-0.75 0.10-0.6  L₃0.10 to 4.0 0.20 to 3.2 0.30 to 2.5 L₄  1.2 to 12.0 L₅ 0.10 to 5.0 0.20to 4.0 0.30 to 3.0

In the course of carrying out the procedure represented in FIGS. 3A-3Eand 6A-6C, during electrosurgical cutting, the temperature imposed atthe tissue confronting the electrode 54 will be well above 100° C. andthe cutting effect, as noted above, causes a destruction of cells,inasmuch as water molecules contained within most tissues commence tovaporize at that temperature. Due to the large increase in volume duringthis phase transition, gas bubbles are formed inducing mechanicalruptures and thermal decomposition of tissue fragments. Gratuitously,this cutting action is quite local, thus, the term “cutting” isappropriate to describe it. The large vaporization heat of water (2253kJ/kg) is advantageous, since the vapor generated carries away excessheat and helps prevent any further increase in the temperature of theadjacent tissue. Fluids in the thus formed “cuts” generated by theelectrode 54 will enhance the electrical connection carried subsequentlyfor purposes of surface coagulation.

As discussed above in connection with FIGS. 13 and 15, remote returns asdescribed at 74 in FIG. 1 can be replaced with a surface electrodegenerally located at the forward end region of the instrument and, moreparticularly, where it can provide a return contact with the tissue ofthe patient. Looking to FIG. 16, such an instrument adaptation isrepresented generally at 340. As before, the instrument 340 includes asupport member forward end region 342 which extends to a trocar shapedtip 344. A slot-shaped deployment portion 346 is seen to extend betweena forward location 348 and a rearward location 350. Shown deployedbetween the abutment defining locations is a thin resilient electrode352 which is supported by the slot-shaped deployment portion 346 inconjunction with electrically insulative sleeves 354 and 356.Insulatively mounted upon the surface of the forward end region 342 ofthe support member is a surface electrode 358. Electrode 358, as noted,functions in replacement of the remote electrode 74 (FIG. 1).

Referring to FIG. 17, an embodiment of the instrument of the inventionemploying two electrodes is represented in general at 360. The forwardend region 362 of the support member 364 of instrument 360 is revealedin the figure. Region 362 extends to a tip 366 which is configuredhaving an annular shoulder 368 which is inserted within the forward endof the tubular support member or cannula 364. Tip 366 is seen to beconfigured as a trocar for purposes of penetration (percutaneous)through the patients' tissue. Positioned immediately rearwardly of thetip 366 is a cylindrical, electrically insulative electrode engagementblock 370 having two rearwardly facing cylindrical openings therein, 372and 374. Opening 374 receives and adhesively secures the distal end ofan inner electrode 376, as well as a forwardly disposed inner electrodesleeve 378. Electrode 376 is seen to extend through and is abutablysupported from an elongate deployment slot 380. Slot 380 as before,extends parallel to the longitudinal axis 382 of the forward end region362 from a forward location 384 to a rearward location 386. Innerelectrode 376 is shown in its outwardly deployed, arch formingorientation extending into slidable engagement with an electricallyinsulative sleeve 388 which, in turn, is fixed within a cylindricalcavity 390. Cavity 390 extends rearwardly within a cylindrical,electrically insulative electrode guide and conduit support 392. Inparticular, the electrode 376 slidably extends within an elongatecylindrical cavity 394 which, in turn, extends to the base region of theinstrument in the manner described in connection with FIG. 13. An upperelectrode 396 is positioned within the deployment slot 380 radiallyabove inner electrode 376. In this regard, electrode 396 is adhesivelyengaged within cylindrical cavity 372 in conjunction with insulativesleeve 398. Electrode 396 is shown in its deployed arch forming profileas extending in slidable relationship through flexible electricallyinsulative sleeve 400. Sleeve 400 is supported by the sides of a cavity402 formed in the electrode guide and conduit support 392. Cavity 402extends as a cylindrical cavity 404 to the base region of instrument360.

Located within the deployment portion 380 and forming a component of theslot is a deflector guide component 406 which, as before, functions tosupport the electrodes 376 and 396 intermediate the forward location 384and rearward location 386. The guide 406 slightly outwardly biases theelectrodes 376 and 396 to facilitate their outward deployment as theyare compressibly urged forwardly to create the arch profile. Electrodes376 and 396 are illustrated in phantom in their retracted, nestedorientation at 376′ and 396′. As before, barrier fluid may be expressedfrom the deployment slot 380 by virtue of a barrier fluid conduit 408extending through the guide 406 to an outlet port 410. The channel 408is configured in the manner of channel 128 as described in FIG. 13 as itextends to the base region of instrument 360.

As is apparent from FIG. 17, the apex dimension or height of the archdefined by electrode 376 is smaller than the corresponding apex heightof the arch profile of electrode 396. Looking to FIG. 18, forward theinstrument 360 at its forward end region 362 again is depictedpictorially in conjunction with longitudinal axis 382 and an arrow 412representing a pivoting or rotation of the forward end region 362 aboutaxis 382. With the dual electrode arrangement shown, the procedure forcarrying out vascular isolation of a targeted tissue volume can beimproved in terms of the time required for requisite maneuvers. Each ofthe electrodes 376 and 396 retain the inherent structural integrity ofthe arch formation of the invention to additionally improve upon thistime element for the procedure involved. As in the previous embodiments,during this procedure, electrosurgical cutting current is applied to theouter electrode 396 and for at least one cut to the inner electrode 376so that a full circumscription of the targeted tissue volume isachieved. The procedure is represented in the maneuvering diagram setforth in FIGS. 19A-19C.

Looking to FIGS. 19A-19C, a section through forward end region 362 isshown as it intersects the electrodes 376 and 396 at the apexes of thearches defined by them when fully deployed. In the figures, theelectrode 376 and electrode 396 apex locations are shown with that samenumeration. The figures further reveal the deployment slot 380, as wellas a section of the deflector guide component 406 and support member362. In FIG. 19A, electrode 396 is shown having been deployed to an apexradius R1 and having completed an electrosurgical cut to that radialextent as represented by the cut indicator line 414. This cut indicatorline 414 will reside in healthy tissue but in adjacency with thetargeted tissue volume 106 peripheral extent. To carry out acircumscription of such tissue, instrument forward end region 362 willhave been oriented angularly as shown and indicated by the angulardesignation θ=0. The deployment of electrode 396 is such that it willpass over the “top” of the targeted tissue 106 peripheral extent.Additionally, electrode 376 will have deployed within the cut tissueinterface represented by the cut indicator line 414 to a radial positionrepresented at R2. This position is located such that, upon pivoting ofthe electrode 376, it will pass “under” the peripheral extent oftargeted tissue 106. Looking to FIG. 19B, the fully deployed electrodes376 and 396 continue to be energized and the forward end region 362 ispivoted as represented by arrow 412 (FIG. 18) to the angular positionθ=θ1. Electrode 396 will remain at the radial distance R1 and electrode376 will remain at the radial distance or deployment R₂. However,electrode 396 will have developed an arc shaped cut across the “top” oftargeted tissue volume 106 as represented by cut indicator line 416.Simultaneously, electrode 376 will have carried out an electrosurgicalcut represented by arc shaped cut indicator line 418. Referring to FIG.19C, the final maneuver is carried out by energizing both electrodes 396and 376 while at the radial angular orientation θ=θ1 and retracting theminto the nested orientation shown. This will generate the cut indicatorlines 420 and 422.

Referring to FIG. 20, an embodiment of the invention establishing aminimally invasive instrument having a relatively small outer diameter,for example, about 0.125 inch is revealed. The forward end region of theinstrument is shown at 430 forming part of a solid, as opposed tocannular support member 432. The material forming support member 432will be selected in accordance with its intended utilization and may beeither flexible or rigid. A rigid arrangement is shown in the instantfigure. The forward end region 430 extends to a trocar-shaped tip 434.As represented additionally in FIGS. 21-23, the support member 432 andits forward end region 430 are unitary or integrally formed and have acylindrical outer periphery disposed about a longitudinal axis 438.Extending in parallel with that axis 438 from a securement region 440adjacent tip 434 toward the base of the instrument is an elongateoutwardly open slot 442. As seen in FIGS. 21-23, the slot 442 hasoppositely disposed sides 444 and 446 that extend a slot depth to a slotbottom 448. The outer periphery of the entire structure, with theexception of tip 434, thus far described is covered with an electricallyinsulative coating 450. Located adjacent bottom surface 448 of the slot442 is a thin, resilient elongate electrode 452 having a distal end 454which extends within the securement region 440. Looking to FIGS. 20 and21, distal end 454 is seen to be positioned within a rigid stainlesssteel tube 456, the outer periphery of which is electrically insulated,for example, with two layers of a shrink wrap which covers the forwardend of the tube adjacent the tip 434. That covering is shown at 458 inFIG. 21. Covering 458 may be dispensed with where, as represented inFIG. 21, the slot 442 is fully electrically insulated at its surface.Electrode 452 is bonded adhesively within the tube 456 and the tube 456,in turn, is retained in position adhesively with a forward retainercomponent 460 positioned within slot 442 above the tube 456 within thesecurement region 440. Tube 456, as well as the securement region 440,extend to a forward location seen in FIG. 20 at 462. As seenadditionally in FIG. 22, electrode 452 continues from forward location462 to extend through a deployment slot region shown generally at 464 toa rearward location 466 terminating region 464. From rearward location466 to the base of the instrument, as in the above-describedembodiments, the electrode 452 slidably extends through a rigidsupporting channel herein implemented as a stainless steel tube orchannel tube 468. As seen in FIG. 23, an annular gap is present betweenthe outer surface of electrode 452 and the channel tube 468.Additionally, the channel tube 468 is seen to be enclosed within anelectrically insulative shrink wrap 472 (FIG. 23). Where a unitarycoating as illustrated at 450 is provided for the instrument, then theshrink wraps as at 472 in FIGS. 23 and 458 in FIG. 21 may be dispensedwith. However, in securement region 440, the outer distal tip of theelectrode 452 must be insulated from tip 434. However, where such shrinkwrap arrangements are provided, insulation within the deployment slotregion 464 preferably will be provided by a thin membranous sheetformed, for example, of an aromatic polyimide marketed under thetrademark “Kapton”. The channel tube 468 is retained within the slot 442by a rearward retainer component 474. This rearward retainer component474, as well as forward retainer component 460 additionally may beretained within the slot 442 by a shrink wrap covering positioned aboutthe periphery 436. Retention of the components 460 and 474 may be withsuch a shrink wrap approach (not shown) or by an application of amedical grade adhesive. As before, the electrode 452 is deployed byurging it forwardly in compression to effect outward movement generallytransversely to the longitudinal axis 438 into an outwardly dependingarch formation represented in phantom at 452′ in FIG. 20. As before, thearch formation 452′ extends from supporting abutments generated by thesides of the slot 442 adjacent forward location 462 and rearwardlocation 466. The electrode 452 is retracted into its nested orinsertion and removal mode orientation by urging it rearwardly formovement toward the slot 442.

FIGS. 24-27 reveal an embodiment corresponding with FIGS. 20-23 butincorporating a barrier fluid delivery channel in conjunction with slot442. Accordingly, where the components of this next embodiment reappearthey are identified by the same numeration but in primed fashion. InFIG. 24, the forward end region of 430′ is shown as a component ofsupport member 432′ and extends to a tip 434′. Support member 432′ iscylindrical and disposed about a longitudinal axis 438′. The cylindricalouter periphery of the instrument is shown in FIGS. 25-27 at 436′.Extending within the solid cylindrical support member 432′ is anelongate slot represented generally at 480. As before, slot 480 extendsalong the longitudinal axis 438′ from a position in adjacency with tip434′ toward the base region. The slot is configured having oppositelydisposed slot sides 482 and 484 (FIGS. 25-27). As shown in FIGS. 24 and25, within the securement region 440 and extending to about the midpointof the deployment slot region 464′, the slot bottom 486 is configuredhaving a depth corresponding with that shown in FIGS. 21-23. However, asrepresented in FIGS. 24 and 26, that depth extends within the deploymentslot region 464′ only to an output location seen in FIG. 24 at 488.Rearwardly of the location 488, the slot depth has a greater dimensionalextent as represented by the slot bottom 490 seen in FIGS. 24, 26 and27. In the present embodiment, adjacent the slot bottom 490 is a barrierfluid delivery channel implemented as a stainless steel tube 492. Asbefore, the slot 480 and support member outer cylindrical periphery 436′is provided with an electrically insulative surface or coating 450′.However, this coating may be implemented by thin membranes or shrinkwrap as discussed in connection with FIGS. 20-23. The conduit 492extends from a remote fluid input at the base region as described inconjunction with FIG. 13 and terminating at the output location 488.Note at FIG. 24 that that output is curved outwardly to promote fluidexpression from the deployment slot region 464′.

The electrode 452′ distal end 454′, as before, is seen to extend withina rigid tube 456′ which may be covered with an electrically insulativeshrink wrap 458′ as seen in FIG. 25. The electrode distal end 454′ isadhesively retained within the tube 456′ within securement region 440′.Tube 456′, in turn, may be adhesively retained within region 440′ andfurther retained by a forward retainer component 460′ positioned withinthe slot 480 and extending, with tube 456′ to the forward location 462′(FIG. 24). In similar fashion electrode 452′ is slidably retained withina channel 468′ herein implemented as a stainless steel tube. Thisslidability is evidenced in FIG. 27 by a gap 470′. As before, tube 468′may be covered with an electrically insulative shrink wrap as at 472′,particularly when the exterior electrically insulative coating 450′ isnot provided along the sides and bottom of slot 480. As before, theassemblage of tubes 492 and 468′ may be retained within the slot 480 bya rearward retainer component 474′.

Electrode 452′ is deployed by urging it forwardly in compression to formthe buttressed arch formation extending between forward location 462′and rearward location 466′ as shown in phantom at 452″ in FIG. 24.Retraction is carried out by urging the electrode 452′ rearwardly toconvert the arch formation at 452″ into a nesting orientation as shownat 452′.

Referring to FIGS. 28-32, one preferred arrangement for the instrumentembodiment of FIGS. 20-27 is revealed. In the figure, the forward endregion 500 of the cylindrical support member 502 is revealed to againhave a solid structuring, the generally cylindrical shape of the region500 being disposed about a longitudinal axis 504. Forward end region 500extends to a pointed tip 506. Extending from an end surface 508 inparallel with the longitudinal axis 504 rearwardly toward the baseregion is an elongate slot represented generally at 510 of a rectangularcross section. Looking in particular to FIGS. 29-32, slot 510 is seen tobe configured having a slot width defined between oppositely disposedslot sides 512 and 514. Sides 512 and 514 extend to a slot bottom 516 ofuniform depth which may extend, in turn, to the base region of theinstrument. Fixed within the slot 510 is a retention insert representedgenerally at 518 (FIGS. 28-31) that may be provided as a unitaryinjection molded, electrically insulative polymeric component. Theforward portion of the retention insert 518 establishes a securementregion represented in FIG. 28 at 520. Looking additionally to FIG. 29,the retention insert 518 is seen to be formed having an outwardlyopening electrode receiving channel with oppositely disposed internalside surfaces 522 and 524 which extend an initial channel depth to anarcuate channel bottom 526. Adhesively secured at this bottom surface526 is an elongate, thin, resilient electrically conductive electrode528 which is so retained at region 520 as not to have an electricalassociation with the material of the forward region 500 of supportmember 502. Positioning at the bottom surface 526 further is assured byan adhesively retained forward retainer component 530 of rectangularcross-section which extends from the end surface 508 to a forwardlocation 532 (FIG. 28). Retention insert 518 extends rearwardly fromforward location 532 within a channel deployment region 534. Here thechannel depth extending to the channel bottom surface 526 diminishes toform a double taper profile seen at 528 exhibiting a depth of leastdimension at the center region 534 at 536. From position 536, thetapering profile returns to the initial depth represented at 526 in FIG.29 at rearward location 538. Location 538 represents the rearwardterminus of channel deployment region 534. The channel depth at thislocation corresponds with the channel depth 526 and the correspondingbottom surface at that location is seen in FIGS. 28 and 31 at 540.

FIGS. 28 and 32 reveal that the electrode 528 is slidably mounted withina rigid, tubular metallic channel 542 having a peripherally disposedelectrically insulative coating or layer which may be implemented as apolymeric shrink wrap and is shown in FIG. 32 at 544. Electrode 528 isslidable within the channel 542 as is represented by the annular gap 546additionally seen in FIG. 32. FIGS. 28 and 32 further reveal that theslot 510 supports a rigid tubular barrier fluid duct or delivery channel548 that additionally is adhesively fixed to channel 542. Fluid deliverychannel 548 extends from a fluid input at the base region, as describedin connection with FIG. 13, to a fluid output seen in FIG. 28 at 550.Note that the forward edge of fluid output 550 extends beyond therearward location 538. FIG. 31 reveals that the sidewalls of thechannel-shaped retention insert 518 additionally have been taperedinwardly such that the cylindrical wall of annular cross section 512 ofthe channel 548 extends over the outward surfaces of the channel sides.This extension is of relatively short distance and is for the purpose ofassuring that barrier fluid enters the channel deployment region 534 andis not blocked by electrode 528 when it is deployed into an archformation represented in phantom at 528′ in both FIGS. 28 and 31. Topermit this deployment while assuring the expression of barrier fluidinto the deployment region 534, the tubular fluid delivery channel 512is slotted to both receive and support electrode 528 as it deploys fromrearward location 538. FIG. 31 reveals that the outward opening slot 552has a width corresponding with the outer diameter of electrode 528 so asto provide structural support to it and further provide oppositelydisposed chord-shaped channel outlet regions 554 and 556 as seen in FIG.31.

As in the earlier embodiments, electrode 528 is deployed by urging itforwardly in compression to effect its outward movement transversely tolongitudinal axis 504 to an extent curving it into an outwardlydepending arch formation as shown in phantom at 528′ in FIGS. 28 and 31.

As noted above, by virtue of a somewhat nercrotized surface of thetissue at the interface of an electrosurgical cut carried out with theinstrument of the invention, a discrete and defined corridor forreception of barrier or necrotizing fluid is evoked. Thus, thepositioning of the barrier or necrotizing fluid within this interface isof substantial accuracy to provide more assurance of a complete butrestricted coverage of the tissue interface to beneficially retard anyrate of neovascularization across the interface. Accuracy of locatingthis barrier or necrotizing fluid at the cut interface can be enhancedby associating the expression of barrier or necrotizing fluid with thelocation of the cutting electrode. In one embodiment of the invention,the electrode is formed having an interior fluid transfer cavity and oneor a plurality of fluid outlets that are formed within the electrode atthe deployment region.

Referring to FIG. 33, an embodiment of the instrument of the inventionemploying an electrode having an internal fluid transfer cavity isrepresented in general at 560. The forward end region 562 of a supportmember 564 of instrument 560 is shown in the figure. Region 564 extendsto a trocar-shaped tip 566, rearwardly from which is located aslot-shaped deployment portion 568. A thin, resilient electrode 570 isshown deployed into an arch formation from the slot-shaped deploymentportion 568. To buttress and electrically isolate the electrode 570 fromthe support member 564, electrode 570 is covered with a flexibleelectrically insulative sheath 572 at a forward end region and isslidably inserted within a corresponding sheath 574 at a rearwardlocation. Seen disposed in radial quadrature about the electrode 570 isan array of fluid outlets, certain of which are revealed at 576. Lookingto FIG. 34, the electrode 570 is seen to be formed having an interiorfluid transfer cavity 578 and the array of fluid outlets or aperturesare again represented at 576. In the arrangement shown, the array isrepresented as four linear arrays at the top, bottom and two sides ofthe electrode, the side array outlets being displaced from thevertically disposed arrays as shown in the figure. Fluid transfer cavity578 is in fluid transfer communication with a barrier fluid deliveryconduit as described, for example, in connection with FIGS. 7, 12 and13. The number of outlets 576 employed will depend upon a number ofhydraulic related factors and may be varied. Of interest, when employedas an array, the compressive force required to deploy electrodes as at570 diminishes.

FIGS. 35A-35E illustrate procedures for maneuvering the instrument 560to carry out a vascular isolation of a targeted tissue volume of givenperipheral extent. As before, these figures are representative of asection taken through the apex of the arch formation of electrode 570 asrevealed in connection with FIG. 33 at section 35-35. The sectionalmaneuvering diagrams are illustrated in connection with a symbolictissue volume 580. In each of the figures, the appropriate section ofelectrode 570 is represented in conjunction with deployment portion slot568 and the forward end region 562 of support member 564. In FIG. 35A,the forward end region 562 of instrument 560 has been positioned withinhealthy, viable tissue in adjacency with the peripheral extent of thetargeted tissue volume 580. The deployment slot 568 has been angularlyoriented at a position designated θ=0 wherein a portion of the surfaceof the forward end region 562 is in adjacency with what may be termedthe “bottom” of the tissue volume 580. Slot 568 is angularly oriented todeploy electrode 570 into an adjacency with what may be termed one sideof tissue volume 580. Accordingly, the electrode 570 iselectrosurgically activated into a cutting mode and is deployed to theorientation represented by radius R1. An electrosurgical cut is shownhaving been made as represented by the dashed cut indicator line 582. Atthis electrode position, electrosurgical excitation of the electrode 570is interrupted and barrier or necrotizing fluid is expressed from thefluid outlet 576 to, in effect, fill the tissue interface developed bythe cut represented at 582. This filling is represented by the filledinterface outline 584.

Electrode 570 then is excited again and the forward end region 562 ofthe instrument 560 is pivoted to the angular orientation θ=θ1 asrepresented at FIG. 35B. Electrode 570 remains at the radial distance R1and will have created an arcuate cut represented by cut indicator line586. At the position shown in the figure, electrosurgical excitation ofthe electrode 570 is interrupted and barrier or necrotizing fluid iscaused to flow from the outlets 576 to fill the interface represented byjoining tissue at the cut 586. This filling is represented by the filledinterface outline 588.

Referring to FIG. 35C, a next maneuver may be to electrosurgicallyexcite electrode 570 while the forward end region 562 is at the angularorientation θ=θ1 and simultaneously retract it toward deployment slot568 as represented by the cut indicator line 592. Such retraction may beterminated at a position above slot 588. At this location, nowdesignated radial distance R2, electrosurgical excitation of theelectrode 570 may be interrupted and the interface developed by the cut592 may be filled with barrier or necrotizing fluid as represented bythe filled interface outline 594. Either of two optional maneuvers maybe carried out at this position in the procedure.

One such optional maneuver, as represented in FIG. 35D, may be electedfor relatively larger volumes of targeted tissue. In that figure, thenext maneuver is to rotate the forward end region 562 from the angularorientation θ=θ1 beneath targeted tissue 580 to the orientation θ=0. Therotation thus brings the electrode into intersection with cut indicatorline 584 as represented by dashed cut indicator line 596. At position570, electrosurgical excitation of the electrode 570 may be interruptedto the extent that it is terminated for the procedure and the cut tissueinterface that is back-filled with barrier or necrotizing fluid isrepresented by the filled interface outline 598. Electrode 570 then isretracted fully within the deployment slot 568.

Another option for the practitioner is represented in connection withFIG. 35E. This procedure typically will involve the vascular isolationof smaller targeted tissue volumes 580. In the figure, following thecompletion of the cut represented at cut indicator line 586 and thefilling of the resultant cut interface as represented at 588, theelectrode 570 is retracted to a position within the deployment portionslot 568, for example to the position shown where the electrode isaligned with the support member surface 590. This cut maneuver isrepresented by dashed cut indicator line 600. From the noted position ofelectrode 570, the tissue interface developed by the cut 600 isback-filled with barrier or necrotizing fluid as represented by thefilled interface outline 602. The procedure for filling interface 600also can be carried out from fully retracted orientation of theelectrode 570 within the deployment slot 568.

By virtue of the insertion of the forward end region 562 of supportmember 564 into adjacency with the “lower” side of the targeted tissuevolume 580, a mechanical cut will be in evidence about its “bottom” sideat cylindrical surface 590. The act of filling the cut 600 with barrierfluid also will tend to fill the interface between surface 590 andtissue. Such filling also may occur with the filling represented at 584carried out in connection with the initial cutting step of theprocedure.

Referring to FIG. 36, another instrument adaptation for expressingbarrier or necrotizing fluid within the electrosurgically cut tissueinterface developed with the system of the invention is revealed. In thefigure, the forward end region 610 of a support member 612 is seenextending to a tip 614. Adjacent tip 614, commencing with a forwardlocation 616, is a slot shaped deployment portion 618 which extends to arearward location 620. The support member 612 is symmetrically disposedabout a longitudinal axis 622 and, as before, slidably supports a thin,resilient electrode 624 having a distal end fixed to the support member612 adjacent the tip 614 and which is electrically insulated from themember 612 by an electrically insulative sleeve 626. Electrode 624extends slidably through an electrically insulative sleeve 628 seenextending through the deployment slot 618 adjacent rearward location620. In the fashion described above, the electrode 624 is compressivelyurged into an arch formation when deployed from an insertion mode ofoperation of the instrument. Alternately, the electrode 624 is retractedby urging it rearwardly from the vicinity of the base region of theinstrument. For the barrier fluid disbursement embodiment of the figure,a barrier fluid delivery conduit is provided which is slidably mountedwithin a fluid delivery channel within support member 612. The flexibleoutput portion of that electrically insulative conduit is shownextending to a barrier fluid outlet 632 located at about the midpoint ofthe deployment portion 618. Conduit portion 630 is coupled to theunderside of the electrode 624 by a sequence of electrically insulativeand heat resistant thin straps 634-636. With the arrangement shown, theconduit component 630 may be deployed by urging it forwardlysimultaneously with the compressive deployment of electrode 624.Alternately, the conduit component 630 may be made of a flexiblematerial permitting it to stretch to the orientation shown. The laterapproach becomes feasible where the instruments are designed for smallertissue volume and the longitudinal extent of translation of electrode624 is quite limited in extent. Guidance and support is supplied to thetubular component 630 during deployment, as well as during retraction bythe side surfaces of the slot 618. With the arrangement, the outlet 632will be positioned essentially at the midpoint of a givenelectrosurgical cut to facilitate dispersing barrier fluid within theelectrosurgical cut interface evolved at the termination of a cutmaneuver. Some flexure may be provided at the strap 634-636 to permitthe flexible tubular component 630 to pivot about the underside ofelectrode 624 to therefore allow it to “follow” the electrode as itcarries out a transverse pivotal or retracting maneuver. However, duringretraction, the side surfaces of the deployment slot 618 will cause thetubular component 630 to reassume the electrode underside orientationshown in FIG. 36 as it approaches a fully nested orientation. A materialsuited for forming the straps 634-636 may, for example, be the earlierdescribed “Kapton” material.

The maneuvering of forward end region 610 as well as electrode 624 andassociated tubular component 630 will emulate the maneuvering describedabove in connection with FIGS. 35A-35E. An initial such maneuver isrepresented in FIG. 37 where the electrode 624 is seen to have beendeployed at a radial angle θ=0 and has produced an electrosurgical cutrepresented by the dashed cut indicator line 638. In this regard, theelectrode 624 has radially deployed a distance indicated as R₁ about oneside of a targeted tissue volume represented at 640. Tubular component630 has, “followed” electrode 624 to this arch apex orientation. Asnoted, the procedure then continues as described in connection with FIG.35.

Some modification of the base region earlier described at 46 of theinstrument of the invention is called for to accommodate for the barrieror necrotizing fluid delivery embodiments of FIGS. 33 and 36. Thesemodifications are illustrated respectively in connection with FIGS. 38and 39-40. Where features of this base region remain in common withthose identified in FIG. 13, they are identified in the instant figureswith the same numeration but in primed fashion. Looking to FIG. 38,instrument 40′ is shown incorporating support member 564 which, at baseregion 46′ is coupled to a removable handle 48′. An actuator assembly isrepresented generally at 56′. For this embodiment, however, theelectrode guide and conduit support, now identified at 650, extends to arearward face 652 and is fixed within the interior of support member564. Electrode 570 (from FIG. 33) slidably extends from the forward endregion along a support channel 654, in essence, from the rearward face652 into cylindrical opening 152′. As described above, the electrode 570is formed having an interior fluid transfer cavity 656 extendingrearwardly to an electrode fluid input 658 within cylindrical opening152′. Electrode 570 is fixed to and extends through electrode driveblock 660 and supports that drive block against rotation. Accordingly,with the rotational actuation of the cylindrical control knob 178′,electrode drive block 660 will be driven forwardly to, in turn. drivethe electrode 570 forwardly an arch defining distance.

To supply barrier fluid to the electrode fluid input 658 and, thus, itsinterior fluid transfer cavity 656, a barrier fluid delivery assemblyrepresented generally at 662 is provided. Assembly 662 includes aflexible tube 664 that extends through a channel 666 formed withinforward base housing 150′. One end of the tube 664 is attached to thefluid input 668 and an amount of “slack” of the tube is folded or woundwithin the chamber 156′ to accommodate for the noted movement of block660. Tube 664 terminates in a fitment 668 configured for attachment witha reservoir of barrier fluid as, for example, will be provided as afluid filled hypodermic syringe.

The base region 46′ for the barrier fluid delivery embodiment of FIG. 36is represented in FIGS. 39 and 40. In FIG. 39, the base end region 46′is shown to include the rearward portion of the support member 612 as itextends to the forward base housing 150′. The electrode guide andconduit support, now as represented at 670, is slidably extending withina channel 572. Channel 572 extends, in turn, to the forward end region610 (FIG. 36). As in the embodiment of FIG. 13, a rigid sleeve 162′ iscoupled with the channel 572 and extends in slidable, supportingrelationship with an electrode drive block 674 slidably mounted withinthe interior of support member 612. Electrode 624 is fixed to the driveblock 674 at lead connector and adhesion position 172′. Thus, as in theembodiment of FIG. 13, actuation of the knob 178′ moves the electrodeforwardly in compression, as well as rearwardly. Support 670 alsoincludes a fluid delivery channel 676 within which is slidably located afluid delivery conduit 678. Conduit 678 extends through and is fixed todrive block 674 and exits from its rear face to a conduit fluid input680.

Barrier fluid is introduced into the conduit fluid input 680 of deliveryconduit 678 from a barrier fluid delivery assembly represented generallyat 682. As before, the assembly 682 includes a flexible delivery tube,for example, formed of silicone which is shown at 684 extending througha fluid delivery channel 686 into cavity 156′ and connection with fluidinput 680. Tube 684 is provided having an extended length or “slack”permitting it to accommodate for the forward movement of drive block674. A fitment 688 is attached to the opposite end of tube the 684 thatis included for connection with a fluid barrier reservoir such as ahypodermic syringe.

Forward end region 610 is shown in FIG. 40. In this regard, the flexibleoutward portion or tube is shown as a discrete component 630 attached tothe fluid outlet 690. With the arrangement, the outlet 690 movesforwardly with the fluid delivery conduit 678 simultaneously with themovement of electrode 624. This deploying movement enhances theflexibility of the flexible tube 630 with respect to its suspensionstraps 634-636 allowing it to “follow” the electrode 624. The sides ofthe slot deployment portion 618, in particular, support and realign thetube 630 beneath the electrode 624 during a retraction procedure as wellas during deployment.

The barrier function for retarding neovascularization may be implementedwith a thin or membranous flexible film or shroud having an outwardlydeployed edge which is pulled behind the deployed arch-shaped electrode.Referring to FIG. 41, the forward end region 700 of a support member 702is depicted incorporating this embodiment. The forward region 700 ofsupport member 702 is cylindrical and is symmetrically disposed about alongitudinal axis 704 extending to a trocar shaped tip 706. A slotshaped deployment region is shown at 708 extending between a forwardlocation 710 and a rearward location 712. Thin, resilient electrode 714is shown in its arch-shaped deployed formation extending from fixedassociation with an electrically insulative sleeve 716 protruding atforward location 710 and is shown in slidable relationship with aflexible electrically insulative sleeve 718 adjacent rearward location712. Suspended by an array 720 of suture-like, anatomically resorbableconnectors attached to the underside of electrode 714 is a thin,flexible, membranous and anatomically resorbable barrier shroud 722. Theouter edge 724 of the shroud 722 is retained in adjacency with theunderside of electrode 714 with an arrangement revealed in FIG. 42.Looking to that figure, electrode 714 is seen to have an internallydisposed cavity 726 and an lower disposed elongate slot 728. Anelectrically insulative connector rod 730 is attached to one end of eachof the connectors of the array 720, the opposite end of which isthreaded through the shroud 722 adjacent its outer edge 724. The shroud722 may be formed of a resorbable material similar to those used in themanufacturer of resorbable sutures such as lactide/glycolide family ofpolymers. The internally disposed portion of the shroud 722 may bewound, for example, upon a freely rotating mandrel (not shown).Following a procedure wherein the shroud 722 has, in effect,circumscribed the targeted tissue, the electrode 714 will have beenretracted and a cylindrical severing member 732 having an annular shapedcutting edge 734 is slid toward and across forward location 710 to severthe shroud 722 at a location in adjacency with the surface of supportmember 702 along the deployment slot 708.

Referring to FIGS. 43A-43D, the preferred maneuvering arrangement forthe instrument of FIG. 41 is sequentially portrayed. As before, thefigures represent a sectional view of forward end region 700 takenthrough the apex of the arch formation evoked with the electrode 714. InFIG. 43A, the instrument is in an insertion mode, the forward end region700 having been inserted within viable tissue in adjacency with targetedtissue represented symbolically at 736. The angular orientation of theforward end region 700 is designated as θ=0. Looking to FIG. 43B, theelectrode 714 is electrosurgically excited into a cutting mode and isdeployed into an arch formation having an arch apex radius shown as R1,the membranous shroud 722 having been withdrawn from its stored locationwithin support member 702 behind electrode 714. This evokes a cuttinglocus along one side of targeted tissue volume 736 to a radial extent R1wherein the electrode 714 may be pivoted with the forward end region 700of the support member 702 over the top of the targeted tissue volume736. Looking to FIG. 43C, the electrode remains deployed at radius R1 asthe forward end region 700 of support member 702 is pivoted to theposition θ=θ1, while the electrode 714 is electrosurgically excited tocarry out an arcuate cut pulling the shroud 722 from its stored locationwithin the deployment slot 708. Note that the shroud 722 has been drawnacross a cylindrical cut surface 740 of the support member 702 as thispivoting activity is carried out from angular orientation θ=0 to θ=θ1.Thus, the shroud 722 is positioned over a tissue cut surface which hasnot been electrosurgically parted. As represented in FIG. 43D, theelectrode 714 then is electrosurgically excited and retracted into thedeployment slot 708, again pulling the shroud 722 behind it along itslocus of cut. Subsequent to the steps represented in this FIG. 43D, thesevering member 732 is urged forwardly to sever the shroud 722 fromconnection with the support member 702.

In the event that it is desired to carry out an electrosurgical cutbelow the targeted tissue 736, then the initial maneuver will be todeploy the electrode 714 to the earlier described radius R2 (FIGS. 19B,19C) and carry out a circumscription maneuver as a pivoting one from θ=0to θ=θ1.

As is apparent from the discourse above, the expression of barrier fluidor necrotizing agent into the tissue interface developed fromelectrosurgical cutting may be achieved with a variety of instrumentmodalities ranging from simply expressing the fluid from the vicinity ofthe deployment slot following a circumscriptive isolation of targetedtissue to the expression of the fluid in the course of the locus ofmovement of the electrode about the developing interface. It should beborne to mind that two additional or supplemental approaches have beendiscussed above. In this regard, one such approach is to employ a“blend” electrosurgical output that carries out both cutting andcoagulation at the cut tissue interface. A similar result can beobtained by reiterating the entire circumscription procedure utilizingthe coagulating output of the electrosurgical generator for exciting theelectrode.

Referring to FIG. 44A, a flowchart looking to the barrier fluidintroduction methodology is set forth. In the figure, the system isshown to start-up, as represented at mode 750, whereupon as isrepresented at arrow 752 and block 754, the instrument 40, which may bedisposable, is inserted within the handle 48. It should be pointed outthat the forward end region portion as well as eventually the entireinstrument 40 may be employed with a variety of manipulative devicesincluding, for instance, robotically performing instrumentation as wellas catheters.

When handle and instrument are coupled together, as represented at arrow756 and block 758, the control assembly of the system interrogates thecoding elements within instrument 40 to automatically select properelectrode excitation parameters. Where that interrogation shows anout-of-range condition or like aberration, then as represented at arrow760 and node 762, the system stops pending correction. Where appropriateparameter selection has been accomplished, then as represented at arrow764 and block 756, visual and aural cues are given to the operator thatthe system is ready. Cueing has been made available, for example, inconjunction with LEDs 22-25 at console 12 as well as LED array 72 andfurther through aural arrangement extending from speaker grill 28. (FIG.1). The procedure then continues as represented at arrow 768 and block770 wherein the working end or forward end region of the instrument isinserted into the patient into adjacency with one side of the targetedtissue volume peripheral extent at an angular orientation represented as0=0. Then, as represented at arrow 772 and block 774, the electrode isdeployed while being electrosurgically excited. This creates the firstcut interface wherein the apex region of the arch created by electrodedeployment is located to be pivotal over the “top” of the peripheralextent of the targeted tissue volume. As represented at arrow 776 andblock 778, for one barrier fluid positioning approach, theelectrosurgical excitation of the electrode is interrupted and barrierfluid is injected within the tissue interface established by thatpreceding cutting activity. Fluid injection may be from the vicinity ofthe electrode itself as discussed in conjunction with FIGS. 33-37 orfrom the region of the deployment slot, as discussed in conjunction withFIGS. 7 through 13, 16, 24 through 27, and 28 through 32.

The procedure continues as represented at arrow 780 which reappears inFIG. 44B extending to block 782 providing, in turn, for the reexcitationof the electrode and rotating of the forward region such that the apexof the electrode passes over the peripheral extent (top) of the targetedtissue volume to a location such that it may circumscribe the oppositeside of the tissue volume upon retractive manipulation.

This procedure then continues as represented at arrow 784 and block 786which provide for the interruption of electrode excitation and theintroduction of barrier fluid or agent into the tissue interfacerepresenting the next proceeding cut. As noted, this can be carried outfrom a conduit having an outlet adjacent the electrode itself or fromthe deployment region of the support member. The methodology continues,as represented at arrow 788, to the maneuver represented at block 790wherein electrosurgical excitation of the electrode again ensues and theelectrode is retracted to the earlier-described radial position R2, alocation just above the surface of the support member as described, forinstance, in connection with FIG. 35C.

As described in connection with arrow 792 and block 794, excitation ofthe electrode then may be stopped and barrier fluid injected into thetissue cut interface just previously formed. Alternately, the interfaceso formed may be filled with barrier fluid from a location at thedeployment portion or slot. This completes a full circumscription of thetargeted tissue volume, an orange segment shaped volume beingcircumscribed electrosurgically about the tissue volume both across itstop and bottom peripheries.

The program then continues as represented at arrow 796 and block 798wherein electrosurgical excitation of the electrode is reinstated andthe forward end region is pivoted to its original rotationalorientation.

An alternative step then may be undertaken, particularly where targetedtissue of relatively smaller volume is under circumscriptive vascularisolation treatment. In this regard, the electrosurgical cut representedat block 798 is dismissed and the electrode is retracted into its fullynested orientation. There will have existed a tissue severance of thetissue volume occasioned by the forward end region surface of thesupport member, for instance as described at 590 in FIG. 35C. While asurface necrosis of the tissue at the resultant cut interface will nothave occurred, its surface extent is quite small and the next succeedingstep additionally may position barrier fluid within that interface.

This alternative approach is represented at dashed arrow 800 and dashedblock 802 which provides an alternate procedure supplanting the stepsrepresented at block 790, 794 and 798. At block 802, a procedure isprovided for exciting the electrode while retracting it to its nestedorientation radially represented herein at R0, a location permitting theexpression of barrier fluid and subsequent removal of the forward endregion from adjacency with the targeted tissue.

The program then may proceed either from block 802 or from block 798 asrepresented at arrow 804 to the step represented at block 806. At thispoint in the procedure, the electrosurgical excitation of the electrodeis terminated and barrier-producing agent is injected into the pathwhich was just cut. With respect to the procedure block 802, fluidinjection is made into the cut interface created by the support memberat the forward end region. The procedure then continues as representedat arrow 808 which reappears in FIG. 44C. Arrow 808 extends to block 810which provides for an alternative method wherein barrier fluid isinjected into the entire circumscriptive tissue cut interface followingthe circumscriptive cutting procedure. As represented by dashed arrowand dashed block 814, another alternative step may be undertaken. Withthis latter procedure, an embodiment wherein barrier fluid is expressedin adjacency with the electrode is provided and the electrodedeployment, pivoting and retraction maneuvers are reiterated whilebarrier fluid is expressed from the vicinity of the electrode.

A further alternative is represented in conjunction with dashed arrow816 and dashed block 818. The procedure described at block 818 is onewherein an electrosurgical coagulating maneuver is carried out asrepeated maneuver wherein circumscription of the targeted tissue volumeoccurs. Such circumscription is performed with the electrode inconjunction with its deployment, pivoting and retraction maneuversdescribed above in combination with a coagulation output evolved fromthe electrosurgical generator 12 (FIG. 1).

The program then continues as represented at dashed arrow 820 leading toblock 822 which again describes the termination of the electrodemanipulation activity wherein it is retracted into its nestedorientation radially designated at R=0.

Arrow 824 and node 826, provide that the devitalizaton of the targetedtissue volume has been completed. Then, as represented at arrow 828 andblock 830, the forward end region or working end of the instrument isremoved from the patient, to terminate the procedure. Alternatively, itmay be applied at a different anatomical location for a next procedure.

As discussed above, the instrumentation of the present invention hasapplication in a variety of electrosurgical procedural modalities inconsequence of the stability of the electrode arch formation and theaccuracy of any resultant electrosurgical cut carried out. One suchapplication is concerned with cardiac dysrhythmias induced by reentrycircuits. A reentry circuit, in the parlance of electrical systems, is arelatively narrow and extensive channel of tissue along which aberrantcurrent, in the nature of a short circuit path passes. Induction of thetachycardia in the past has been carried out with a intravascularcatheter carrying positioning electrodes which are used to manipulate acatheter tip into adjacency with a targeted interior wall of the heart.Electrosurgically ablating current is delivered to a monopolarelectrosurgically ablating performance at the tip of the catheter for aninterval of about five to ten seconds to achieve a desiredelectrophysiologic effect. Such tissue ablation is relatively expansivein extent. Where the desired effect is not achieved in a given attempt,then the catheter is repositioned and the procedure reiterated atdifferent locations along the myocardium. Generally, thiselectrosurgical activity occurs for twenty to sixty seconds to produce amaximal lesion. The procedure is generally successful and carries outthe formation of an impedance based interruption of the reentry circuitby evoking an electrosurgically developed impedance to current flow. Thepresent embodiment of the invention avoids the use of an ablation formtreatment modality in favor of the accuracy of the deployed arch-formingelectrode.

Referring to FIG. 45, a schematic section of a heart wall is shown at840 having an endocardial interior heart wall surface 842. Wall surface842 will surmount a heart chamber represented at 844 such as the rightor left ventricle. The figure shows the path of a reentry circuit 846.In carrying out the treatment modality of the invention, anintravascular catheter 852 (FIG. 46) is configured to incorporate a tiphaving a modified forward end region 854 of the instrument of theinvention. This will include a noted deployment region slot 848 and thinresilient electrode 850 which is deployable in compression bymanipulation from the base region of the catheter into an arch formationwhile being electrosurgically excited to carry out an electrosurgicalcut defined by the thin electrode between its forward and rearwardlocations. Catheter 852, with its modified tip, is percutaneouslyinserted into the patient and intravascularily guided to the positionwithin the chamber 844. The deployment region slot portion of the tip ofthe instrument is shown at 848 having deployed an electrode 850 into anarch formation while being electrosurgically excited to provide a cutwith an impedance defining tissue interface. Looking additionally toFIG. 46, the reentry circuit 846 is seen to be, as discussed above, arelatively narrow or discrete path for current flow, while the electrode850 of catheter 852 is seen to be deployed in an arch formationelectrosurgically having cut through the myocardium 842 and past thelocation of the circuit path 846. The catheter 852 will have guided itsforward end region 854 into adjacency with the heart interior wallsurface 842 such that the deployment slot or portion 848 extends acrossor embraces the region of path 846. This positioning of the catheter 852and forward end region 854 is carried out by two positioning surfaceelectrodes as are conventionally employed with this procedure and areshown at spaced apart locations 856 and 858. Such positioning is carriedout by remotely observing alterations in electrical parameters such asimpedance variation, occasioned by of the reentry circuit 846. With thepresent invention, however, it is necessary to position the deploymentslot portion 848 into appropriate adjacency with the heart wall surface842. This is achieved by providing surface electrodes 860 and 862 at theforward end region 854 which are of limited circumferential extent andaligned with the deployment slot portion 848 and which may respond insimilar manner as electrodes 856 and 858, but only when the slot 848 isadequately adjacent the wall 842. Transverse transection of heart wall840 then is carried out. The degree of transverse orientation of theslot and electrode 850 is dependent simply upon the requirement forinterrupting reentry circuit path 846 an amount effective to gain normalheart function. This interruption, for example, achieved through animpedance formation within the reentry circuit path by the generation ofan necrotic tissue interface. The procedure may be performed using aconventional electrosurgical cutting excitation of electrode 850 or witha “blend” cutting activity.

Referring to FIG. 47, a flowchart describing the procedure for utilizingthe embodiment of FIGS. 45 and 46 is set forth. In the figure, theprocedure commences as represented at block 870. The modifiedintravascular catheter is introduced into an artery or vein dependingupon which chamber of the heart that is involved with the reentrycircuit. Then, as represented at arrow 872 and block 874 the distal orforward end region of the catheter is positioned adjacent the abnormalelectrical pathway or reentry circuit. As represented at arrow 876 andblock 878, it is necessary to orient the catheter so that the deployingelectrode is facing the interior heart wall and is generally transverseto the circuit path 846. In the latter regard, it is necessary tointerrupt the path and establish a form of tissue interface developedimpedance to the flow of current along the path. As noted above, thismay be carried out in conjunction with surface electrodes 860 and 862(FIG. 46). As represented at arrow 880 and block 882, as the electrodeis deployed, it is electrosurgically excited either with a cutting orblend output waveform and deployment continues as the condition of thereentry circuit 846 is monitored. When interruption of that circuit isachieved, either with a single or with multiple positioning of theforward end region 854, then, as represented at arrow 884 and block 886the electrode 850 is retracted into a nested orientation within thedeployment slot 848. Then, as represented at arrow 888 and block 890,the catheter is removed or moved to the next location.

The instrument architecture described above has been one wherein thethin, resilient electrically conductive electrode has been mounted inelectrical isolation from the support member. For example, in FIG. 7,electrode 54 is seen to be electrically insulated by sleeves as at 86and 88 and extends through an electrically insulative guide and conduitsupport 136. In a preferred arrangement, however, the componentssupporting the electrode are in electrical contact with it and thus,they are at the same potential during intervals of electrode excitation.The support member itself, however, is covered with a thin but effectivelayer of insulation such that it is safely electrically isolated fromthe patient. Accordingly, arcing phenomena between components isavoided.

Referring to FIG. 48, the forward end region of an instrumentincorporating this preferred architecture is represented generally at900. Region 900 incorporates an electrically conductive cylindricalsupport member 902 which may, for example, be formed of stainless steel.This member 902 is symmetrically disposed about an axis 904 and is seento extend to an integrally formed or pointed trocar-type tip 906.Extending through the support member 902 is an elongate bore 908 thatterminates in an end surface 910. As in the earlier embodiments, supportmember 902 incorporates a slot-shaped deployment portion 912 extendingalong the axis 904 from a forward location 914 to a rearward location916. Extending within the bore 908 is an elongate thin, resilient andelectrically conductive electrode 918, the distal end 920 of which isfixed within a securement region 922 of bore 908. In this regard, thedistal tip of the electrode 918 preferably is fixed in abuttingrelationship with the end surface 910. In a preferred arrangement, thefixing of the distal end 920 is carried out with a quadrature basedcrimping procedure. Looking to FIG. 49, four compressive crimpindentations are represented at 924-927 developing respectivecompressive attachments 928-931.

As in the earlier embodiment, the electrode 918 is deployed from thedeployment portion 912 by being compressively urged forwardly to assumean arch formation represented, for example, at 918′ in phantom. Lookingadditionally to FIG. 50, the electrode 918 within the deployment portion916 is seen to be slightly bent outwardly within the slot-shapeddeployment portion 912. In this regard, note that the electrode, ingeneral, extends above the bottom surface 934 of the bore 908 as itextends along the slot-shaped deployment portion 912. Electrode 918additionally is seen to extend rearwardly from the rearward location 916within the bore 908. This slidable relationship is represented in FIG.51 by the annular gap 936.

An electrically insulating layer is disposed on the exterior surfaces ofthe support member 902 as is represented at 938. Note that the layer 938covers the tip region 906 and extends over the edges of slot-shapeddeployment region 912. This extension of the coating is shown in FIG. 50at 940 extending over deployment slot side surface 942 and at 944extending over the deployment slot side surface 946. Similarly, FIG. 48reveals that the insulative coating extends over rearward location 916as at 948 and over forward location 914 as at 950. A suitableelectrically insulating material is a vapor-phase-polymerized conformalcoating marketed under the trade designation “Parylene”. Coatings areavailable from Parylene Coating Surface Companies such as SpecialtyCoating Systems, of Indianapolis, Ind. The insulative material 938 willhave a thickness from about 0.0002 inch to 0.020 inch and preferably ina range of about 0.0005 inch to 0.003 inch.

Since certain changes may be made in the above-described apparatus,method and system without departing from the scope of the inventionherein involved, it is intended that all matter contained in thedescription thereof or shown in the accompanying drawings shall beinterpreted as illustrative and not in a limiting sense.

1. (canceled)
 2. The system of claim 6 in which: said electrosurgicalgenerator is responsive to a second control input to generate a secondoutput for carrying out electrosurgical coagulation; and said controlassembly is actuable in correspondence with a repetition of saidelectrode deployment and retraction to effect derivation of said secondcontrol input and the application of said second output to saidelectrode in electrical association with said electrosurgical return. 3.The system of claim 6 in which: said electrosurgical generator isresponsive to a third control input for carrying out electrosurgicalcutting and coagulation; and said control assembly is actuable incorrespondence with said electrode deployment and retraction to effectderivation of said third control input and the application of said thirdoutput to said electrode in electrical association with saidelectrosurgical return.
 4. The system of claim 6 including: a returnelectrode mounted upon said support member as a component of saidexternal surface at a location in electrical coupling association withsaid tissue when said electrode is deployed and retracted; and saidcontrol assembly is configured to couple said electrosurgical returnwith said return electrode.
 5. (canceled)
 6. A system for cutting abouta volume of targeted tissue exhibiting a given peripheral extentcomprising: an electrosurgical generator having an electrosurgicalreturn responsive to a first control input to generate a first outputfor carrying out electrosurgical cutting; a support member having anexternal surface and extending along a longitudinal axis between a baseregion and a tip, having a forward end region extending along alongitudinal axis from said tip and positionable in an insertion modeinto adjacency with said tissue volume peripheral extent and saidforward end region having a deployment portion adjacent said tip; tip,said deployment portion comprising an outwardly open slot extendingalong said longitudinal axis between a forward location and a rearwardlocation having a slot width and extending inwardly along oppositelydisposed slot side surfaces said support member being rotatable aboutsaid axis subsequent to said insertion mode. a thin, resilient electrodehaving a deployable portion extending within said forward end regiondeployment portion slot during said insertion mode, deployable to moveoutwardly from two spaced apart locations between said deploymentportion forward location and said rearward location to an outercircumscription location adjacent said tissue peripheral extent thenrotatable with said support member along said tissue peripheral extentand then retractable to move toward said deployment portion tosurgically isolate said targeted tissue; a portion of said electrodehaving a distal end fixed to said support member at a connectionlocation adjacent said forward location and moveable outwardly from saidslot generally transversely to said longitudinal axis when deployed toexhibit an arch formation extensible toward said circumscriptionlocation and being configured to define an arch supporting abutment withsaid slot sides adjacent said forward location and said rearwardlocation when deployed and retracted effective to buttress saiddeployable portion when said support member is rotated about saidlongitudinal axis; an actuator assembly extending along said supportmember from said base region, coupled with said electrode and actuablefor effecting the deployment thereof by urging said electrode forwardlyin compression to effect said outward movement thereof to saidcircumscription location and to effect the retraction thereof by urgingit rearwardly thereof; to cause inward movement thereof toward saiddeployment portion; a control assembly in electrical communication withsaid electrosurgical generator and said electrode actuable incorrespondence simultaneously with said electrode deployment, rotationand retraction to effect derivation of said first control input and theapplication of said first output to said electrode in electricalcommunication with said electrosurgical return said support memberforward end region electrode deployment portion is outwardly open,extending along said forward end region between a forward locationadjacent said tip and a rearward location; said electrode is thin andresilient, extending within said deployment portion during saidinsertion mode, having a distal end connected with said support memberat a connection location adjacent said forward location and extending aninner arch defining distance less than said electrode arch definingdistance beyond said rearward location; said actuator assembly isconfigured to deploy said inner electrode by urging it forwardly incompression to effect outward movement thereof generally transversely tosaid longitudinal axis along a locus substantially defined by saiddeployment of said electrode into an outwardly depending arch formationwith an inner electrode apex representing an inner maximum displacementfrom said longitudinal axis less than said electrode apex, and extendingsubstantially between said forward location and said rearward location,and said actuator assembly effecting retraction of said inner electrodeby urging it rearwardly to effect inward movement thereof toward saiddeployment portion; and said control assembly is electrically coupledwith said inner electrode and is responsive to effective application ofsaid first output thereto.
 7. (canceled)
 8. The system of claim 6 inwhich: said support member includes one or more of a fluid deliverychannel extending from a fluid input in the vicinity of said base regionto a fluid output at said forward end region, a reservoir for retaininga supply of barrier fluid coupled with said fluid input for effectingthe expression of said barrier fluid through a fluid delivery channelextending from a fluid input in the vicinity of said base region, and aconduit for conveying fluid extending from said support member forwardregion to said base region.
 9. (canceled)
 10. The system of claim 11 inwhich a second fluid outlet is located adjacent said forward end region.11. The system of claim 6 in which: said electrode is formed having aninterior fluid transfer cavity, an electrode fluid input in fluidtransfer relationship with said fluid transfer cavity and at least onefluid outlet in fluid transfer communication with said fluid transfercavity at said forward end region assembly; and said support memberincludes a barrier fluid delivery assembly extending in fluid transferrelationship from a fluid input to said electrode fluid input. 12-13.(canceled)
 14. Apparatus for electrosurgically cutting a targeted regionof tissue, of given peripheral extent utilizing the output, including areturn, of an electrosurgical generator, comprising: a rigid supportmember extending between a tip and a base region, having a forward endregion extending along a longitudinal axis from said tip andpositionable in an insertion mode into adjacency with said peripheralextent of said targeted region of tissue, and having a sidewallcontaining deployment portion at said forward end region adjacent saidtip which is outwardly open, extending between a forward location and arearward location said support member being rotatable about said axissubsequent to said insertion mode; a thin, resilient electrode extendingwithin said deployment portion during said insertion mode and deployableto move outwardly from between said forward and rearward locations todefine an arch-shaped electrode cutting portion extending outwardly ofsaid tissue region peripheral extent when said support member is rotatedand retractable subsequent to said rotation of said support member tomove toward said deployment portion, said deployment portion beingconfigured adjacent said forward and rearward locations to provide abuttressing engagement with said electrode effective to support saidelectrode when said support member is rotated; and an actuator andelectrical circuit assembly extending along said support member fromsaid base region, mechanically connected with said electrode foreffecting said deployment and retraction thereof, and having a terminalassembly electrically connectable with said generator for coupling afirst said applied output to said electrode providing, in operativeassociation with said return, electrosurgical cutting of said tissue bysaid electrode along said cutting portion during said deployment, whendeployed during rotation of said support member, and during saidretraction. 15-16. (canceled)
 17. The apparatus of claim 14 in which:said support member includes one or more of a fluid delivery channelextending from a fluid input in the vicinity of said base region to afluid output at said forward end region; said actuator and electricalcircuit assembly including a reservoir for receiving a barrier fluid influid transfer communication with said fluid input, and a pump actuableto effect the expression of said barrier fluid from said fluid output,and a conduit for conveying fluid extending from said support memberforward end region to said base region.
 18. (canceled)
 19. The apparatusof claim 14 in which: said support member forward end region issubstantially cylindrical and said deployment portion includes anoutwardly open slot extending along said longitudinal axis from asecurement end adjacent said tip to a rearward location, havingoppositely disposed said sidewalls extending a slot depth to a slotbottom, and said forward end region having an electrically insulative,generally channel-shaped retention insert fixed within said slot, havingan outwardly opening electrode receiving channel with oppositelydisposed internal side surfaces extending a channel depth to a channelbottom, having a securement region extending at a first channel depthfrom said slot securement end to a forward location, thence extendingalong a channel deployment region having a second depth, thence having arearward location with a channel depth corresponding with said firstchannel depth; said electrode having a distal end fixed within saidretention insert securement region at said channel bottom and extendingtherefrom along said channel deployment region and beyond said rearwardlocation an arch defining distance; and said actuator assembly isconfigured to deploy said electrode by urging it forwardly incompression to effect outward movement thereof generally transversely tosaid longitudinal axis to an extent curving it into an outwardlydepending arch formation defining said cutting portion and effectingretraction of said electrode by urging it rearwardly to effect inwardmovement thereof toward said slot.
 20. The apparatus of claim 19 inwhich said retention insert second channel depth is less than said firstchannel depth an amount effective to mechanically bias said electrodeoutwardly during said insertion mode. 21-25. (canceled)
 26. The systemof claim 17 in which: said support member includes a deflector guidecomponent located within said electrode deployment portion intermediatesaid forward location and said rearward location; and said electrode isin freely abutting, outwardly biased relationship with said deflectorguide during said insertion mode. 27-34. (canceled)
 35. Apparatus forelectrosurgically cutting a targeted region of tissue, utilizing theoutput, including a return, of an electrosurgical generator, comprising:a support member extending between a tip and a base region, having aforward end region extending along a longitudinal axis from said tip andpositionable in an insertion mode into adjacency with said targetedregion of tissue, and having a deployment portion at said forward endregion adjacent said tip; said support member forward end region beingsubstantially cylindrical and said deployment portion including anoutwardly open slot extending along said longitudinal axis from asecurement region adjacent said tip to a forward location, thence alonga deployment slot region to a rearward location, having a slot widthdefined between oppositely disposed slot sides extending a slot depth toa slot bottom, including an electrically insulative surface located atsaid slot sides and bottom, said support member forward end region slotdepth exhibiting a first dimensional extent from said securement regionto an output location, and exhibiting a second dimensional extentgreater than said first dimensional extent therefrom rearwardly towardsaid base region, said support member including a barrier fluid deliverychannel having a fluid input in the vicinity of said base region andextending within said slot beneath said electrode to said outputlocation, a thin, resilient electrode extending within said deploymentportion during said insertion mode and deployable to move outwardly fromtwo spaced apart support locations to define an electrode cuttingportion and retractable to move toward said deployment portion; saidelectrode having a distal end positioned within said slot securementregion and extending an arch defining distance beyond said rearwardlocation; an actuator and electrical circuit assembly extending alongsaid support member from said base region, mechanically connected withsaid electrode for effecting said deployment and retraction thereof, andhaving a terminal assembly electrically connectable with said generatorfor coupling a first said applied output to said electrode providing, inoperative association with said return, electrosurgical cutting of saidtissue by said electrode along said cutting portion when deployed;including a forward retainer component positioned over said electrodewithin said slot securement region and retaining it within said slot,and a rearward retainer component positioned within said slot over saidelectrode, said electrode being slidably mounted there beneath; and saidactuator assembly being configured to deploy said electrode by urging itforwardly in compression to effect outward movement thereof generallytransversely to said longitudinal axis to an extent curving it into anoutwardly depending arch formation, and effecting retraction of saidelectrode by urging it rearwardly to effect inward movement thereoftoward said slot.
 36. (canceled)
 37. A system for cutting about a volumeof targeted tissue exhibiting a given peripheral extent, comprising: anelectrosurgical generator, having an electrosurgical return, responsiveto a first control input to generate a first output for carrying outelectrosurgical cutting; a support member having an external surface andextending along a longitudinal axis between a base region and a tip,having a forward end region extending along a longitudinal axis fromsaid tip and positionable in an insertion mode into adjacency with saidtissue volume peripheral extent, and said forward end region having adeployment portion adjacent said tip, said deployment portion comprisingan outwardly open slot extending along said longitudinal axis between aforward location and a rearward location, having a slot width andextending inwardly along oppositely disposed slot side surfaces, saidsupport member being rotatable about said axis subsequent to saidinsertion mode, said support member forward end region beingcylindrical, said slot extends inwardly along said oppositely disposedelectrically insulative slot side surfaces to an electrically insulativeslot bottom surface, said support member including a barrier fluiddelivery channel having a fluid input in the vicinity of said baseregion and an electrically insulative fluid outlet having apredetermined channel width and a channel slot and extending within saidopen slot in adjacency with said rearward location; a thin, resilientelectrode having a deployable portion extending within said forward endregion deployment portion slot during said insertion mode, deployable tomove outwardly between said deployment portion forward location and saidrearward location to an outer circumscription location adjacent saidtissue peripheral extent then rotatable with said support member alongsaid tissue peripheral extent and then retractable to move toward saiddeployment portion to surgically isolate said targeted tissue saidelectrode having a distal end fixed to said support member at aconnection location adjacent said forward location and moveableoutwardly from said slot generally transversely to said longitudinalaxis when deployed to exhibit an arch formation extensible toward saidcircumscription location, and being configured to define an archsupporting abutment with said slot sides adjacent said forward locationand said rearward location when deployed and retracted effective tobuttress said deployable portion when said support member is rotatedabout said longitudinal axis, said electrode extending above said fluidoutlet; an actuator assembly extending along said support member fromsaid base region, coupled with said electrode and actuable for effectingthe deployment thereof by urging said electrode forwardly in compressionto effect said outward movement thereof to said circumscription locationand to effect the retraction thereof by urging it rearwardly to causeinward movement thereof toward said deployment portion; and a controlassembly in electrical communication with said electrosurgical generatorand said electrode, actuable simultaneously with said electrodedeployment, rotation and retraction to effect derivation of said firstcontrol input and the application of said first output to said electrodein electrical communication with said electrosurgical return.
 38. Asystem for cutting about a volume of targeted tissue exhibiting a givenperipheral extent, comprising: an electrosurgical generator, having anelectrosurgical return, responsive to a first control input to generatea first output for carrying out electrosurgical cutting; a supportmember having an external surface and extending along a longitudinalaxis between a base region and a tip, having a forward end regionextending along a longitudinal axis from said tip and positionable in aninsertion mode into adjacency with said tissue volume peripheral extent,and said forward end region having a deployment portion adjacent saidtip, said deployment portion comprising an outwardly open slot extendingalong said longitudinal axis between a forward location and a rearwardlocation, having a slot width and extending inwardly along oppositelydisposed slot side surfaces, said support member being rotatable aboutsaid axis subsequent to said insertion mode, said support member forwardend region having a generally cylindrical outer surface extending tosaid tip, is formed of electrically conductive material, saidcylindrical outer surface and said tip being covered with anelectrically insulative material; a thin, resilient electrode having adeployable portion extending within said forward end region deploymentportion slot during said insertion mode, deployable to move outwardlybetween said deployment portion forward location and said rearwardlocation to an outer circumscription location adjacent said tissueperipheral extent then rotatable with said support member along saidtissue peripheral extent and then retractable to move toward saiddeployment portion to surgically isolate said targeted tissue saidelectrode having a distal end fixed to said support member at aconnection location adjacent said forward location and moveableoutwardly from said slot generally transversely to said longitudinalaxis when deployed to exhibit an arch formation extensible toward saidcircumscription location, and being configured to define an archsupporting abutment with said slot sides adjacent said forward locationand said rearward location when deployed and retracted effective tobuttress said deployable portion when said support member is rotatedabout said longitudinal axis, said electrode being electrically coupledwith said support member; an actuator assembly extending along saidsupport member from said base region, coupled with said electrode andactuable for effecting the deployment thereof by urging said electrodeforwardly in compression to effect said outward movement thereof to saidcircumscription location and to effect the retraction thereof by urgingit rearwardly to cause inward movement thereof toward said deploymentportion; and a control assembly in electrical communication with saidelectrosurgical generator and said electrode, actuable simultaneouslywith said electrode deployment, rotation and retraction to effectderivation of said first control input and the application of said firstoutput to said electrode in electrical communication with saidelectrosurgical return.
 39. Apparatus for electrosurgically cutting atargeted region of tissue, of given extent utilizing the output,including a return, of an electrosurgical generator, comprising: a rigidsupport member extending between a tip and a base region, having aforward end region extending along a longitudinal axis from said tip andpositionable in an insertion mode into adjacency with said peripheralextent of said targeted region of tissue, and having a sidewallcontaining deployment portion at said forward end region adjacent saidtip which is outwardly open, extending between a forward location and arearward location said support member being rotatable about said axissubsequent to said insertion mode, said support member including adeflector guide component located within said electrode deploymentportion intermediate said forward location and said rearward location; athin, resilient electrode extending within said deployment portionduring said insertion mode and deployable to move outwardly from betweensaid forward and rearward locations to define an arch-shaped electrodecutting portion extending outwardly of said tissue region peripheralextent when said support member is rotated and retractable subsequent tosaid rotation of said support member to move toward said deploymentportion, said electrode being positioned in freely abutting relationshipwith said deflector guide component during said insertion mode; saiddeployment portion being configured adjacent said forward and rearwardlocations to provide a buttressing engagement with said electrodeeffective to support said electrode when said support member is rotated;and an actuator and electrical circuit assembly extending along saidsupport member from said base region, mechanically connected with saidelectrode for effecting said deployment and retraction thereof, andhaving a terminal assembly electrically connectable with said generatorfor coupling a first said applied output to said electrode providing, inoperative association with said return, electrosurgical cutting of saidtissue by said electrode along said cutting portion during saiddeployment, when deployed during rotation of said support member, andduring said retraction.
 40. A system for electrosurgically cutting atargeted region of tissue exhibiting a given peripheral extent,comprising: an electrosurgical generator assembly, having anelectrosurgical return, responsive to a first control input to generatea first output for carrying out electrosurgical cutting; a supportmember extending between a base and tip region, having a forward endregion extending along a longitudinal axis from said tip andpositionable in an insertion mode into adjacency with said peripheralextent of said targeted region of tissue, and said forward end regionhaving a sidewall containing deployment portion which is outwardly openadjacent said tip extending between a forward location adjacent said tipand a rearward location, said support member being rotatable about saidaxis subsequent to said insertion mode; a thin, resilient electrodehaving a deployable portion extending within said forward end regiondeployment portion during said insertion mode, deployable to movetransversely outwardly from said longitudinal axis to outwardly of saidperipheral extent of said region of tissue define an electrode cuttingportion extending substantially between said forward location and saidrearward location then rotatable with said support member along saidtissue peripheral extent and retractable to move toward said deploymentportion, said electrode being configured having predetermined length;said deployment portion being configured adjacent said forward andrearward locations to provide a buttressing engagement with saidelectrode during rotation of said support member; an actuator assemblyextending along said support member from said base region, coupled withsaid electrode and actuable for effecting the deployment and retractionthereof; a control assembly in electrical communication with saidelectrosurgical generator and said electrode, actuable during saidelectrode deployment, when deployed during rotation of said supportmember, and during said retraction to effect derivation of said firstcontrol input and the application of said first output to said electrodein electrical communication with said electrosurgical return. saidcontrol assembly including an electrical coding component mounted withsaid support member and exhibiting an electrical parameter correspondingwith said predetermined length; and said electrosurgical generatorincluding a decoding circuit electrically coupled with said controlassembly, responsive to electrically interrogate said electrical codingcomponent to derive a corresponding selection signal, and is responsiveto said selection signal to generate a predetermined said first outputfor carrying out electrosurgical cutting corresponding with saidpredetermined dimension.